[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17136-17137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7212]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2010-M-0519, FDA-2010-M-0556, FDA-2010-M-0558, FDA-
2010-M-0557, and FDA-2010-M-0591]
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
[[Page 17137]]
(PMAs) 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, 301-796-
6570.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the Agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
In accordance with section 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, 2010, through December 31,
2010, and includes one denial action during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the date of action.
Table 1--List of PMA Activity From October 1, 2010, Through December 31, 2010
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PMA No. Docket No. Applicant Trade name Date of action
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P100016........................... FDA-2010-M-0556...... Aaren Scientific, Inc EC-3 intraocular lens Approved October 19, 2010.
(IOL) and EC-3 precision
aspheric lens (PAL) IOL.
P040005 (S005).................... FDA-2010-M-0558...... Dako Denmark A/S..... HER 2 FISH PharmDx kit.... Approved October 20, 2010.
P980018 (S010).................... FDA-2010-M-0557...... Dako Denmark A/S..... HercepTest kit............ Approved October 20, 2010.
P080009........................... ..................... Ethicon Endo-Surgery, SEDASYS computer-assisted Denied October 27, 2010.
Inc. personalized sedation
system.
P080018........................... FDA-2010-M-0591...... Carestream Health, Kodak DirectView CR Approved November 3, 2010.
Inc. mammography system.
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II. Electronic Access
Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.
Dated: March 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-7212 Filed 3-25-11; 8:45 am]
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