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Home » 2021 Issues » 86 FR (03/24/2021) » 2021-06052. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

  2021-06052. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications  

  • Start Preamble

    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-Start Printed Page 156872018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-2019-M-2522, FDA-2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-3652, FDA-M-3845, FDA-2019-M-3862, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-2248, and FDA-2020-M-2339 for “Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    Dharmesh Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289.

    End Further Info End Preamble Start Supplemental Information

    SUPPLEMENTARY INFORMATION:

    I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is published in the Federal Register. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.

    The regulations provide that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from October 1, 2018, through December 31, 2020. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.

    Table 1—List of Safety and Effectiveness Summaries for Approved PMAs and Safety and Probable Benefit Summaries for Approved HDEs Made Available From October 1, 2018, Through December 31, 2020

    PMA No., Docket No.ApplicantTrade nameApproval date
    P180003, FDA-2018-M-3841Veryan Medical LtdBioMimics 3D Vascular Stent System10/4/2018
    P150040/S003, FDA-2018-M-3842Carl Zeiss Meditec, IncVisuMax Femtosecond Laser10/4/2018
    P160054/S008, FDA-2018-M-3983Thoratec CorpHeartMate 3 Left Ventricular Assist System10/18/2018
    P100040/S036, FDA-2018-M-4033Medtronic VascularValiant NavionTM Thoracic Stent Graft System10/19/2018
    P180010, FDA-2018-M-4205W.L. Gore & Associates, IncGORE Carotid Stent11/1/2018
    P150002, FDA-2018-M-4580Cordis CorpCordis INCRAFT® AAA Stent Graft System11/27/2018
    Start Printed Page 15688
    P120016/S024, FDA-2018-M-4582Cardiva Medical, IncVASCADE® MVP Venous Vascular Closure System11/27/2018
    P180007, FDA-2018-M-4665Spiration, IncSpiration® Valve System12/3/2018
    P160034, FDA-2018-M-4672Cardiac Science CorpPowerheart® G3 Pro AED12/6/2018
    P160033, FDA-2018-M-4675Cardiac Science CorpPowerheart® G5 AED, Powerheart® AED G3 Plus, And Powerheart® AED G312/7/2018
    P160043/S012, FDA-2018-M-4777Medtronic VascularResolute OnyxTM Zotarolimus-Eluting Coronary Stent System12/14/2018
    P110013/S088, FDA-2018-M-4778Medtronic VascularResolute Integrity Zotarolimus-Eluting Coronary Stent System12/14/2018
    P100018/S015, FDA-2018-M-4779Micro Therapeutics, Inc. d/b/a ev3 NeurovascularPipelineTM Flex Embolization Device12/14/2018
    P150038/S006, FDA-2018-M-4780InSightec, IncExablate Model 4000 Types 1.0 and 1.1 System (Exablate Neuro)12/16/2018
    P170018, FDA-2018-M-4916Physio-Control, IncLIFEPAK® CR2 Defibrillator12/21/2018
    P170032, FDA-2019-M-0027Sequent Medical, IncWoven EndoBridge (WEB) Aneurysm Embolization System12/31/2018
    P180001, FDA-2019-M-0028William Cook Europe ApSZenith® Dissection Endovascular System12/31/2018
    P170037, FDA-2019-M-0505OPKO Diagnostics, LLCSangia Total PSA Test1/30/2019
    P180025, FDA-19M-2526Essential Medical, IncMANTATM Vascular Closure Device2/1/2019
    P170036, FDA-2019-M-0645Spinal Kinetics LLCM6-CTM Artificial Cervical Disc2/6/2019
    P160050, FDA-2019-M-0802Intrinsic TherapeuticsBarricaid® Anular Closure Device (ACD)2/8/2019
    P170030, FDA-2019-M-0885Biotronik, IncOrsiro Sirolimus Eluting Coronary Stent System (Orsiro Stent System)2/22/2019
    P170042/S002, FDA-2019-M-0995C.R. Bard, IncCOVERATM Vascular Covered Stent3/1/2019
    P160002/S009, FDA-2019-M-1310Ventana Medical System, IncVENTANA PD-L1 (SP142) Assay3/8/2019
    P180037, FDA-2019-M-1214Bard Peripheral Vascular, Inc. (BPV)VENOVO Venous Stent System3/13/2019
    P100009/S028, FDA-2019-M-1251Abbott Vascular, IncMitraClip NT Clip Delivery System; MitraClip NTR/XTR Clip Delivery System3/14/2019
    P180036, FDA-2019-M-1313Impulse Dynamics (USA), IncOPTIMIZER Smart System3/21/2019
    P180040, FDA-2019-M-1465Fidia Pharma USA, IncTRILURONTM3/26/2019
    P180032, FDA-2019-M-1506Channel Medsystems, IncCerene® Cryotherapy Device3/28/2019
    P170027, FDA-2019-M-1582TherOx, IncTherOx DownStream System4/2/2019
    P180034, FDA-2019-M-1763Intact Vascular, IncTack Endovascular System® (6F)4/11/2019
    P180043, FDA-2019-M-1979QIAGEN Manchester Ltdtherascreen® FGFR RGQ RT-PCR Kit4/12/2019
    P180024, FDA-2019-M-1848BAROnova, IncTransPyloric Shuttle/TransPyloric Shuttle Delivery Device4/16/2019
    P180029, FDA-2019-M-1998Boston Scientific CorpLOTUS EdgeTM Valve System4/23/2019
    P180014, FDA-2019-M-2052XVIVO Perfusion, IncXVIVO Perfusion System (XPSTM) with STEEN SolutionTM Perfusate4/26/2019
    P180013, FDA-2019-M-2193Boston Scientific CorpVICI VENOUS STENT® System5/2/2019
    P180031, FDA-2019-M-2408Stryker NeurovascularNeuroform Atlas® Stent System5/16/2019
    H180002, FDA-2019-M-2522Novocure, LtdNovoTTFTM-100L System5/23/2019
    P190001, FDA-2019-M-2560QIAGEN GmbHtherascreen PIK3CA RGQ PCR Kit5/24/2019
    P190004, FDA-2019-M-2561QIAGEN GmbHtherascreen PIK3CA RGQ PCR Kit5/24/2019
    P160013/S002, FDA-2019-M-2671TransMedics, IncOrgan Care System (OCSTM) Lung System5/31/2019
    P160036, FDA-2019-M-2732DT MedTech, LLCHintermann Series H3TM Total Ankle Replacement System6/4/2019
    P160048/S006, FDA-2019-M-2753Senseonics, IncEversense Continuous Glucose Monitoring System6/6/2019
    P160029, FDA-2019-M-2782Philips Medical Systems, IncHeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A)6/6/2019
    P150013/S014, FDA-2019-M-3309Dako North America, IncPD-L1 IHC 22C3 pharmDx6/10/2019
    P000025/S104, FDA-2019-M-3513MED-EL CorpMED-EL Cochlear Implant System7/19/2019
    P150013/S016, FDA-2019-M-3652Dako North America, IncPD-L1 1HC 22C3 pharmDx7/30/2019
    P140031/S085, FDA-2019-M-3845Edwards Lifesciences LLCEdwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System8/16/2019
    H190005, FDA-2019-M-3863Zimmer Biomet Spine, IncThe TetherTM—Vertebral Body Tethering System8/16/2019
    P180050, FDA-2019-M-3862CVRx, IncBAROSTIM NEO® System8/16/2019
    P130021/S058, FDA-2019-M-3844Medtronic CoreValve LLCMedtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System8/16/2019
    H170001, FDA-2019-M-4007ApiFix, LtdMinimally Invasive Deformity Correction (MID-C) System8/23/19
    Start Printed Page 15689
    P040020/S087, FDA-2019-M-4153Alcon Laboratories, IncAcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50 and TFNT60)8/26/2019
    P190006, FDA-2019-M-4186Axonics Modulation Technologies, IncAxonics Sacral Neuromodulation System9/6/2019
    P930016/S057, FDA-2019-M-4238AMO Manufacturing USA, LLCiDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems9/9/2019
    P190011, FDA-2019-M-4928DiaSorin IncLIAISON XL MUREX HCV Ab LIAISON XL MUREX Control HCV Ab10/18/2019
    P190014, FDA-2019-M-4978Myriad Genetic Laboratories, IncMyriad myChoice® CDx10/23/2019
    P180046, FDA-2019-M-5393Axonics Modulation Technologies, IncAxonics Sacral Neuromodulation System11/13/2019
    P180035, FDA-2019-M-5438CooperVision, IncMiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear11/15/2019
    P190008, FDA-2019-M-5534Medtronic, IncIN.PACTTM AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter11/21/2019
    P190016, FDA-2019-M-5605Tusker Medical, IncTula® System11/25/2019
    P180047, FDA-2019-M-5683DiaSorin, IncLIAISON QuantiFERON—TB Gold Plus, LIAISON Control QuantiFERON—TB Gold Plus and LIAISON QuantiFERON Software11/26/2019
    P170019/S006, FDA-2019-M-5741Foundation Medicine, IncFoundationOne® CDx12/3/2019
    P170038, FDA-2019-M-5857AbbottCentriMag Circulatory Support System12/6/2019
    P180027, FDA-2019-M-5961MicroVention, IncFlow Re-Direction Endoluminal Device (FRED®) System12/16/2019
    P140009/S039, FDA-2020-M-0097Abbott Medical, IncAbbott InfinityTM DBS System1/2/2020
    P180038, FDA-2020-M-0107DiaSorin, IncLIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc1/2/2020
    P190018, FDA-2020-M-0108Alcon Research, IncClareonTM Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model Number: SY60WF); ClareonTM Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model Numbers: CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and CNW0T9); ClareonTM Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMeTM Pre-loaded Delivery System (Model Number: CNA0T0); ClareonTM Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMeTM Pre-loaded Delivery System (Model Numbers: CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8 and CNA0T9)1/7/2020
    P170023, FDA-2020-M-0495Contura International A/SBulkamid® Urethral Bulking System1/28/2020
    P170022, FDA-2020-M-0985ARJ Medical, IncPyloPlus UBT System2/18/2020
    P180039, FDA-2020-M-0984DiaSorin IncLIAISON® XL MUREX Anti-HBs; LIAISON® XL MUREX Control Anti-HBs; LIAISON® XL MUREX Anti-HBs Verifiers2/21/2020
    P930014/S126, FDA-2020-M-0986Alcon Laboratories, IncAcrySofTM IQ VivityTM Extended Vision Intraocular Lens (Model DFT015); AcrySofTM IQ VivityTM Toric Extended Vision IOLs (DFT315, DFT 415, DFT515); AcrySofTM IQ VivityTM Extended Vision UV Absorbing IOL (DAT015); AcrySofTM IQ VivityTM Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515)2/26/2020
    P190024, FDA-2020-M-1083Ventana Medical Systems, IncCINtec® PLUS Cytology3/10/2020
    P120006/S031, FDA-2020-M-1126Endologix, IncAltoTM Abdominal Stent Graft System3/13/2020
    P980033/S050, FDA-2020-M-1115Boston Scientific CorpVENOUS WALLSTENT3/17/2020
    P970051/S172, FDA-2020-M-1116Cochlear AmericasNucleus 24 Cochlear Implant System3/17/2020
    P190025, FDA-2020-M-1175Abbott Molecular, IncAlinity m HCV3/23/2020
    P140029/S021, FDA-2020-M-1214Q-Med AB, a Galderma affiliateRestylane® Kysse3/26/2020
    P190028, FDA-2020-M-1213Roche Molecular Systems, Inccobas HPV for use on the cobas 6800/8800 Systems4/3/2020
    P190027, FDA-2020-M-1286Intact Vascular, IncTack Endovascular System® (4F, 1.5-4.5mm)4/10/2020
    P050010/S020, FDA-2020-M-1267Centinel Spine, LLCprodisc® L Total Disc Replacement4/10/2020
    P130008/S039, FDA-2020-M-1299Inspire Medical Systems, IncInspire® Upper Airway Stimulation (UAS)4/14/2020
    Start Printed Page 15690
    P190026, FDA-2020-M-1290QIAGEN GmbHtherascreen® BRAF V600E RGQ PCR Kit4/15/2020
    P170019/S013, FDA-2020-M-1300Foundation Medicine, IncFoundationOne® CDx (F1CDx)4/17/2020
    P190015, FDA-2020-M-1311Bolton Medical IncTREO® Abdominal Stent-Graft System5/4/2020
    P170019/S011, FDA-2020-M-1358Foundation Medicine, IncFoundationOne® CDx (F1CDx)5/6/2020
    P160028, FDA-2020-M-1367Philips Medical Systems, IncHeartStart FR3 Defibrillators Models 861388 (Text) and 861389 (ECG Display), Primary Battery (Models 989803150161, 989803150171), Rechargeable Battery (Model 989803150241), Charger for the Rechargeable Battery (Model 861394), SmartPads III (Models 989803149981, 989803149991), DP pads (Models 989803158211, 989803158221), and Pediatric Key (Model 989803150031)5/11/2020
    P180028, FDA-2020-M-1368Philips Medical Systems, IncHeartStart FRx Defibrillator (861304), Primary Battery (M5070A), Aviation FRx Battery (989803139301), SMART Pads II (989803139261), and Infant/Child Key (989803139311)5/11/2020
    P150025/S013, FDA-2020-M-1410Dako North America, IncPD-L1 IHC 28-8 pharmDx5/15/2020
    P170019/S015, FDA-2020-M-1420Foundation Medicine, IncFoundationOne® CDx5/19/2020
    P110033/S047, FDA-2020-M-1527AllerganJUVÉDERM® VOLUMATM XC6/12/2020
    P190021, FDA-2020-M-1583Mainstay Medical LtdReActiv8 Implantable Neurostimulation System6/16/2020
    P170019/S016, FDA-2020-M-1612Foundation Medicine, IncFoundationOne® CDx (F1CDx)6/16/2020
    P200014, FDA-2020-M-1600Roche Molecular Systems, Inccobas® EZH2 Mutation Test6/18/2020
    P100010/S098, FDA-2020-M-1613Medtronic, IncArctic Front AdvanceTM Cardiac Cryoablation Catheter Arctic Front Advance ProTM Cardiac Cryoablation Catheters FreezorTM MAX Cardiac Cryoablation Catheter CryoConsole Manual Retraction Kit6/23/2020
    P130013/S035, FDA-2020-M-1715Boston Scientific CorpWATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System7/21/2020
    P190031, FDA-2020-M-1724Ventana Medical Systems, IncVENTANA HER2 Dual ISH DNA Probe Cocktail7/28/2020
    P180031/S001, FDA-2020-M-1726Stryker NeurovascularNeuroform Atlas® Stent System7/30/2020
    P200010, FDA-2020-M-1748Guardant Health, IncGuardant360® CDx8/7/2020
    P190007, FDA-2020-M-1752Cardinal HealthKendallTM Multi-Function Defibrillation Electrodes, Medi-TraceTM Cadence Multi-Function Defibrillation Electrodes, Physio-Control/Stryker QUIK-COMBO Pacing/Defibrillation/ECG Electrodes8/7/2020
    P150003/S058, FDA-2020-M-1760Boston Scientific CorpSYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM); SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-WireTM); SYNERGYTM XD Everolimus-Eluting Platinum Chromium Coronary Stent System (MonorailTM)8/10/2020
    P190032, FDA-2020-M-1821Foundation Medicine, IncFoundationOne Liquid CDx8/26/2020
    P180048, FDA-2020-M-1783Diasorin, IncLIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg8/29/2020
    P180049, FDA-2020-M-1822Diasorin, IncLIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control Anti-HBe8/29/2020
    P180045, FDA-2020-M-1828Diasorin, IncLIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM8/29/2020
    P200013, FDA-2020-M-1830Abbott Molecular, IncAlinity m HBV8/29/2020
    P190017, FDA-2020-M-1829Diasorin, IncLIAISON® XL MUREX HBsAg Qual; LIAISON® MUREX Control HBsAg Qual; LIAISON® XL MUREX HBsAg Confirmatory Test8/29/2020
    P200015, FDA-2020-M-1835Edwards Lifesciences, LLCEdwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System8/31/2020
    P160017/S076, FDA-2020-M-1838Medtronic Minimed, IncMiniMed 770G System8/31/2020
    P140031/S112, FDA-2020-M-1868Edwards Lifesciences, LLCEdwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System9/9/2020
    P200022, FDA-2020-M-1986Simplify Medical, IncSimplify® Cervical Artificial Disc9/18/2020
    P160042/S010, FDA-2020-M-2021Prollenium Medical Technologies, IncRevanesse® Lips+9/21/2020
    Start Printed Page 15691
    H190001, FDA-2020-M-2248HDL Therapeutics, IncPlasma Delipidation System (PDS-2TM System)12/1/2020
    P190030, FDA-2020-M-2288Theragen, IncActaStim-S Spine Fusion Stimulator12/9/20
    P200030, FDA-2020-M-2339W. L. Gore and Associates, IncGORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC)12/22/20

    II. Electronic Access

    Persons with access to the internet may obtain the documents at https://www.fda.gov/​MedicalDevices/​ProductsandMedicalProcedures/​DeviceApprovalsandClearances/​PMAApprovals/​default.htm.

    Start Signature

    Dated: March 15, 2021.

    Lauren K. Roth,

    Acting Principal Associate Commissioner for Policy.

    End Signature End Supplemental Information

    [FR Doc. 2021-06052 Filed 3-23-21; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
03/24/2021
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2021-06052
Pages:
15686-15691 (6 pages)
Docket Numbers:
Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2
PDF File:
2021-06052.pdf
Supporting Documents:
» Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
» Premarket Approval Package for P170030, BIOTRONIK, Inc., Orsiro Sirolimus Eluting Coronary Stent, Approved 2/2/2019