2013-06429. Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. 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 Division of Dockets Management.

ADDRESSES:

Submit written requests for copies of summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please cite the appropriate docket number as listed in table 1 of this document when submitting a written request. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT:

Nicole Wolanski, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 placed on the Internet. 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 quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from October 1, 2012, through December 31, 2012. 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 Made Available From October 1, 2012, Through December 31, 2012

PMA No., Docket No.	Applicant	Trade name	Approval date
P110038, FDA-2012-M-1012	Bolton Medical Inc	Relay® Thoracic Stent-Graft with Plus Delivery System	September 21, 2012.
P110042, FDA-2012-M-1048	Cameron Health, Inc	Subcutaneous Implantable Defibrillator (S-ICD®) System	September 28, 2012.
P100003, FDA-2012-M-1039	Globus Medical, Inc	Secure-C Artificial Cervical Disc	September 28, 2012.
P120005, FDA-2012-M-1049	Dexcom, Inc	Dexcom G4 PLATINUM Continuous Glucose Monitoring System	October 5, 2012.
P120006, FDA-2012-M-1110	TriVascular, Inc	Ovation Abdominal Stent Graft System	October 5, 2012.
P120007, FDA-2012-M-1066	Gen-Probe, Inc	APTIMA® HPV 16 18/45 Genotype Assay	October 12, 2012.
P110008, FDA-2012-M-1085	Paradigm Spine, LLC	coflex® Interlaminar Technology	October 17, 2012.
P110039, FDA-2012-M-1084	InSightec, Inc	InSightec ExAblate® System	October 18, 2012.
P110021, FDA-2012-M-1088	Edwards Lifesciences, LLC	Edwards SAPIENTM Transcatheter Heart Valve	October 19, 2012.
P100040/S008, FDA-2012-M-1109	Medtronic Vascular	Valiant® Thoracic Stent Graft with the Captivia Delivery System	October 26, 2012.
P100012, FDA-2012-M-1111	NuVasive, Inc	PCM® Cervical Disc System	October 26, 2012.
P120002, FDA-2012-M-1183	Cordis Corporation	S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent Systems.	November 7, 2012
P100022, FDA-2012-M-1146	Cook, Inc	Zilver PTX Drug-Eluting Peripheral Stent	November 14, 2012.
P100047, FDA-2012-M-1184	HeartWare, Inc	HeartWare® Ventricular Assist System	November 20, 2012.
P120008, FDA-2012-M-1176	Abbott Laboratories	ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls	November 28, 2012.

II. Electronic Access

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

Dated: March 15, 2013.

Leslie Kux,

Assistant Commissioner for Policy.