Document ID: FDA-2010-M-0519-0003
Agency: fda
Document Type: Notice
Title: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications; Availability
Posted Date: 2011-03-28T04:00Z

[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17136-17137]
From the Federal Register Online via the Government Printing 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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