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Home » 2022 Issues » 87 FR (06/08/2022) » 2022-12371. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

  2022-12371. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications  

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    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 January 1, 2021, through February 14, 2022. 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. This is the last notice of this kind considering FDA's rule discontinuing the practice of publishing such summaries in the Federal Register . As indicated in that rule, FDA will continue to publish to make available on the internet and place on public display summaries of safety and effectiveness for approved PMAs.

    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-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-2021-M-0531, FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-2021-M-0766, FDA-2021-M-0676, FDA- Start Printed Page 34885 2021-M-0690, FDA-2021-M-0656, FDA-2021-M-0494, FDA-2021-M-0915, FDA-2021-M-0911, FDA-2021-M-0853, FDA-2021-M-0805, FDA-2021-M-1046, FDA-2021-M-1010, FDA-2021-M-0991, FDA-2021-M-0989, FDA-2021-M-0975, FDA-2021-M-0962, FDA-2021-M-1176, FDA-2021-M-1119, FDA-2021-M-1116, FDA-2021-M-0532, FDA-2021-M-1058, FDA-2021-M-1182, and FDA-2021-M-1023, FDA-2021-M-1207, FDA-2021-M-1284, FDA-2021-M-1271, FDA-2021-M-1317, FDA-2021-M-1321, FDA-2021-M-1316, FDA-2021-M-1325, FDA-2021-M-1352, FDA-2022-M-0029, FDA-2022-M-0071, FDA-2022-M-0087, FDA-2022-M-0089, FDA-2022-M-0090, and FDA-2022-M-0171 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, Dharmesh.Patel@fda.hhs.gov.

    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.

    Prior to February 14, 2022, the regulations provided that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced in the Federal Register . FDA issued a rule discontinuing this practice on January 13, 2022 (87 FR 2042). At that time, FDA committed to continue to publish lists of safety and effectiveness summaries of PMA approvals and denials on its website. The following list of approved PMAs for which summaries of safety and effectiveness that were placed on the internet from January 1, 2021, through February 14, 2022, will, therefore, be our last such list to be published in this manner. There were no denial actions during this period. The list in table 1 provides the manufacturer's name, the product's generic name or 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 January 1, 2021, Through February 14, 2022

    PMA No., docket No.ApplicantTrade nameApproval date
    P200003, FDA-2021-M-0070Seno Medical Instruments, IncImagio® Breast Imaging System1/11/21
    P200028, FDA-2021-M-0135Medtronic, IncDiamondTemp TM Ablation System consisting of DiamondTemp TM AblaDiamondTemp Ablation Catheter (Models CEDT100S, CEDT200L, CEDTB300S, CEDTB400L); DiamondTemp TM RF Generator (Model CEDTG200); DiamondTemp TM Irrigation Pump (Model CEDTP100); DiamondTemp TM Irrigation Tubing Set (Model CEDTTS100); DiamondTemp TM Catheter-to-RF Generator Cable (Model CEDTC100); DiamondTemp TM GenConnect Cable (Model CEDTGC100); DiamondTemp TM EGM Cable (Model CEDTEGM100)1/28/2021
    P140029/S027, FDA-2021-M-0153Q-Med ABRestylane® Defyne1/29/2021
    P190005, FDA-2021-M-0178Roche DiagnosticsElecsys Anti-HBe, PreciControl Anti-HBe2/3/2021
    P200039, FDA-2021-M-0202Shockwave Medical, IncShockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter2/12/2021
    P190013, FDA-2021-M-0288AED Battery Exchange, LLCAED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)2/13/2021
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    H200001, FDA-2021-M-0203Additive Orthopaedics, LLCPatient Specific Talus Spacer2/17/2021
    P190034, FDA-2021-M-0228Roche DiagnosticsElecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck2/23/2021
    P200029, FDA-2021-M-0303Boston Scientific CorporationTheraSphere TM3/17/2021
    P200025, FDA-2021-M-0325Bausch HealthClearVisc Ophthalmic Viscosurgical Device (OVD)3/23/2021
    P200046, FDA-2021-M-0354Medtronic, IncMedtronic Harmony Transcatheter Pulmonary Valve (TPV) System3/26/2021
    P200022/S003, FDA-2021-M-0355Simplify Medical, IncSimplify® Cervical Artificial Disc4/1/2021
    P200019, FDA-2021-M-0416Ventana Medical Systems, IncVENTANA MMR RxDx Panel4/22/2021
    P980040/S124, FDA-2021-M-0421Johnson & Johnson Surgical Vision, IncTECNIS Synergy TM IOL, Model ZFR00V, TECNIS Synergy TM Toric II IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, TECNIS Synergy TM IOL with TECNIS Simplicity TM Delivery System, Model DFR00V, TECNIS Synergy TM Toric II IOL with TECNIS Simplicity TM Delivery System, Model DFW150, DFW225, DFW300, DFW3754/28/2021
    P200002, FDA-2021-M-0418AtriCure, IncEPi-Sense® Guided Coagulation System4/28/21
    P140031/S125, FDA-2021-M-0473Edwards Lifesciences, LLCEdwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System5/13/21
    P200010/S001, FDA-2021-M-0520Guardant Health, IncGuardant360 CDx5/21/2021
    P110027/S012, FDA-2021-M-0531QIAGEN GmbHtherascreen® KRAS RGQ PCR Kit5/28/2021
    P110033/S053, FDA-2021-M-0527AllerganJUVÉDERM® VOLBELLA® XC5/28/2021
    P200010/S002, FDA-2021-M-0494Guardant Health, IncGuardant360 CDx5/28/2021
    P100010/S110, FDA-2021-M-0690Medtronic, IncArctic Front AdvanceTM Cardiac Cryoablation Catheters, Arctic Front Advance ProTM Cardiac Cryoablation Catheters, FreezorTM MAX Cardiac Cryoablation Catheter, CryoConsole Manual Retraction Kit6/18/2021
    P200021, FDA-2021-M-0615Oticon MedicalNeuro Cochlear Implant System6/23/2021
    P110019/S115, FDA-2021-M-0656Abbott VascularXIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary Stent Systems (XIENCE Sierra EECSS), and the XIENCE Skypoint Everolimus Eluting Coronary Stent Systems (XIENCE Skypoint EECSS)6/25/2021
    P140029/S032, FDA-2021-M-0676Q-Med AB, a Galderma affiliateRestylane® Contour6/28/2021
    P200017, FDA-2021-M-0766Siemens Healthcare Diagnostics IncADVIA Centaur® Anti-HBe2 (aHBe2) assay7/14/2021
    P190032/S001, FDA-2021-M-0707Foundation Medical, IncFoundationOne® Liquid CDx (F1 Liquid)7/15/21
    P130022/S039, FDA-2021-M-0769Nervo CorporationSenza® Spinal Cord Stimulation (SCS) System7/16/2021
    P200037, FDA-2021-M-0820Kestra Medical Technologies, IncASSURE® Wearable Cardioverter Defibrillator (WCD) System (ASSURE System)7/27/2021
    P200011, FDA-2021-M-0853Pillar Biosciences, IncONCO/Reveal TM Dx Lung & Colon Cancer Assay7/30/2021
    P200045, FDA-2021-M-0805Bolton Medical, IncRelayPro Thoracic Stent-Graft System8/5/2021
    P200049, FDA-2021-M-0911Abbott MedicalAmplatzer TM Amulet TM Left Atrial Appendage Occluder8/14/2021
    P210001, FDA-2021-M-0915Ventana Medical Systems, IncVENTANA MMR RxDx Panel8/17/2021
    P160045/S028, FDA-2021-M-0962Life Technologies CorporationOncomine® Dx Target Test8/25/2021
    P210007, FDA-2021-M-0991MicroTransponder IncMicroTransponder® Vivistim® Paired VNS TM System (Vivistim® System)8/27/2021
    P050052/S129, FDA-2021-M-0975Merz North America, IncRADIESSE® (+) Lidocaine injectable implant9/1/2021
    P180051, FDA-2021-M-0989TransMedics, IncOrgan Care System (OCS TM ) Heart System9/3/2021
    P160045/S029, FDA-2021-M-1023Life Technologies CorporationOncomine TM Dx Target Test9/15/2021
    P190023, FDA-2021-M-1010Abbott MedicalPortico TM Transcatheter Aortic Valve Implantation System: Portico TM Transcatheter Aortic Heart Valve, FlexNav TM Delivery System, FlexNav TM Loading System9/17/2021
    P200004, FDA-2021-M-1046ConMed CorporationConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters9/26/2021
    P200031, FDA-2021-M-1058TransMedics, IncOrgan Care System (OCS TM ) Liver9/28/2021
    P210026, FDA-2021-M-1116Agilent Technologies, IncKi-67 IHC MIB-1 pharmDx (Dako Omnis)10/12/2021
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    P190012, FDA-2021-M-1119Spatz FGIA IncSpatz3 Adjustable Balloon System10/15/2021
    P160046/S010, FDA-2021-M-0532Ventana Medical Systems, IncVENTANA PD-L1 (SP263) Assay10/15/2021
    P150031/S040, FDA-2021-M-1176Boston Scientific CorporationVercise PC, Vercise Gevia and Vercise Genus DBS Systems10/20/2021
    P150038/S014, FDA-2021-M-1182INSIGHTEC, IncExablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)10/29/21
    P130026/S070, FDA-2021-M-1207Abbott MedicalTactiCath Contact Force Ablation Catheter, Sensor Enabled (Uni-Directional); TactiCath Contact Force Ablation Catheter, Sensor Enabled (Bi-Directional); TactiSys Quartz Equipment; Ampere RF Generator and Cool Point Irrigation Pump11/4/21
    P210020, FDA-2021-M-1284Urotronic, IncOptilume® Urethral Drug Coated Balloon12/3/21
    P190022, FDA-2021-M-1271OPKO Health, Inc4Kscore® Test12/7/21
    P200035, FDA-2021-M-1317OrganOx LimitedOrganOx metra® System12/9/21
    P210014, FDA-2021-M-1321Svelte Medical Systems, IncSLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System12/13/21
    P200041, FDA-2021-M-1316OrbusNeich Medical (Shenzhen) Co., LtdScoreflex NC Scoring PTCA Catheter12/21/21
    P200015/S011, FDA-2021-M-1325Edwards Lifesciences LLCEdwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent12/16/21
    P200040, FDA-2021-M-1352Delphinus Medical Technologies, IncSoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly10/6/21
    P170002/S012, FDA-2022-M-0029TEOXANE S.ARHA® Redensity TM12/22/21
    P970051/S205, FDA-2022-M-0071Cochlear AmericasNucleus 24 Cochlear Implant System1/10/22
    P130022/S042, FDA-2022-M-0087Nevro CorporationSenza® Spinal Cord Stimulation (SCS) System1/18/22
    P840001/S469, FDA-2022-M-089Medtronic NeuromodulationRestore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord Stimulation Leads1/21/22
    P080012/S068, FDA-2022-M-0090Flowonix Medical, IncPrometra® Programmable Infusion Pump System1/12/22
    P160048/S016, FDA-2022-M-0171Senseonics, IncorporatedEversense® E3 Continuous Glucose Monitoring System2/10/22

    II. Electronic Access

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

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    Dated: June 2, 2022.

    Lauren K. Roth,

    Associate Commissioner for Policy.

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    [FR Doc. 2022-12371 Filed 6-7-22; 8:45 am]

    BILLING CODE 4164-01-P

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Document Information

Published:
06/08/2022
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2022-12371
Pages:
34884-34887 (4 pages)
Docket Numbers:
Docket Nos. FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2
PDF File:
2022-12371.pdf
Supporting Documents:
» Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications
» Premarket Approval Response from FDA CDRH to OrganOx Limited