Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Federal Register, Volume 78 Issue 55 (Thursday, March 21, 2013)
Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)
Notices
Pages 17415-17416
From the Federal Register Online via the Government Printing Office www.gpo.gov
FR Doc No: 2013-06429
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket Nos. FDA-2012-M-1012, FDA-2012-M-1039, FDA-2012-M-1048, FDA-
2012-M-1049, FDA-2012-M-1066, FDA-2012-M-1084, FDA-2012-M-1085, FDA-
2012-M-1088, FDA-2012-M-1109, FDA-2012-M-1110, FDA-2012-M-1111, FDA-
2012-M-1146, FDA-2012-M-1176, FDA-2012-M-1183, and FDA-2012-M-1184
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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:
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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 Sec. 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.
Page 17416
Table 1--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2012,
Through December 31, 2012
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PMA No., Docket No. Applicant Trade name Approval date
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P110038, FDA-2012-M-1012.......... Bolton Medical Inc... Relaysupreg September 21, 2012.
Thoracic Stent-Graft
with Plus Delivery
System.
P110042, FDA-2012-M-1048.......... Cameron Health, Inc.. Subcutaneous September 28, 2012.
Implantable
Defibrillator (S-
ICDsupreg) System.
P100003, FDA-2012-M-1039.......... Globus Medical, Inc.. Secure-C Artificial September 28, 2012.
Cervical Disc.
P120005, FDA-2012-M-1049.......... Dexcom, Inc.......... Dexcom G4 PLATINUM October 5, 2012.
Continuous Glucose
Monitoring System.
P120006, FDA-2012-M-1110.......... TriVascular, Inc..... Ovation Abdominal October 5, 2012.
Stent Graft System.
P120007, FDA-2012-M-1066.......... Gen-Probe, Inc....... APTIMAsupreg HPV 16 October 12, 2012.
18/45 Genotype Assay.
P110008, FDA-2012-M-1085.......... Paradigm Spine, LLC.. coflexsupreg October 17, 2012.
Interlaminar
Technology.
P110039, FDA-2012-M-1084.......... InSightec, Inc....... InSightec October 18, 2012.
ExAblatesupreg
System.
P110021, FDA-2012-M-1088.......... Edwards Lifesciences, Edwards SAPIENTM October 19, 2012.
LLC. Transcatheter Heart
Valve.
P100040/S008, FDA-2012-M-1109..... Medtronic Vascular... Valiantsupreg October 26, 2012.
Thoracic Stent Graft
with the Captivia
Delivery System.
P100012, FDA-2012-M-1111.......... NuVasive, Inc........ PCMsupreg Cervical October 26, 2012.
Disc System.
P120002, FDA-2012-M-1183.......... Cordis Corporation... S.M.A.R.T.supreg November 7, 2012
CONTROLsupreg and
S.M.A.R.T.supreg
Vascular Stent
Systems..
P100022, FDA-2012-M-1146.......... Cook, Inc............ Zilver PTX Drug- November 14, 2012.
Eluting Peripheral
Stent.
P100047, FDA-2012-M-1184.......... HeartWare, Inc....... HeartWaresupreg November 20, 2012.
Ventricular Assist
System.
P120008, FDA-2012-M-1176.......... Abbott Laboratories.. ARCHITECT AFP Assay, November 28, 2012.
ARCHITECT AFP
Calibrators and
ARCHITECT AFP
Controls.
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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.
FR Doc. 2013-06429 Filed 3-20-13; 8:45 am
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