[Federal Register Volume 78, Number 55 (Thursday, March 21, 2013)]
[Notices]
[Pages 17415-17416]
From the Federal Register Online via the Government Publishing 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:
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
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... Relay[supreg] 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-
ICD[supreg]) 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....... APTIMA[supreg] HPV 16 October 12, 2012.
18/45 Genotype Assay.
P110008, FDA-2012-M-1085.......... Paradigm Spine, LLC.. coflex[supreg] October 17, 2012.
Interlaminar
Technology.
P110039, FDA-2012-M-1084.......... InSightec, Inc....... InSightec October 18, 2012.
ExAblate[supreg]
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... Valiant[supreg] October 26, 2012.
Thoracic Stent Graft
with the Captivia
Delivery System.
P100012, FDA-2012-M-1111.......... NuVasive, Inc........ PCM[supreg] Cervical October 26, 2012.
Disc System.
P120002, FDA-2012-M-1183.......... Cordis Corporation... S.M.A.R.T.[supreg] November 7, 2012
CONTROL[supreg] 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....... HeartWare[supreg] 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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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.
[FR Doc. 2013-06429 Filed 3-20-13; 8:45 am]
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