[Federal Register Volume 64, Number 235 (Wednesday, December 8, 1999)]
[Notices]
[Pages 68695-68696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-31699]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket Nos. 99M-0293, 99M-2168, 99M-2672, 99M-2605, 99M-2671, 99M-
2338, 99M-1167, 99M-1306, 99M-1073, 99M-2143, 99M-2606, 99M-2169, 99M-
2144, 99M-2748, 99M-2551, and 99M-4134]


Medical Devices; Availability of Safety and Effectiveness 
Summaries for PMA

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 application (PMA) approvals. This list is intended to inform 
the public of the availability of safety and effectiveness summaries of 
approved PMA's through the Internet and the agency's Dockets Management 
Branch.

ADDRESSES: Summaries of safety and effectiveness are available on the 
Internet at http://www.fda.gov/cdrh/pmapage.html. Copies of summaries 
of safety and effectiveness are also available by submitting a written 
request to the Dockets Management Branch (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 in the 
Supplementary Information section of this document when submitting a 
written request.

FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2186.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 30, 1998 
(63 FR 4571), FDA published a final rule to revise Secs. 814.44(d) and 
814.45(d) (21 CFR 814.44(d) and 814.45(d)) to discontinue publication 
of individual PMA approvals and denials in the Federal Register. 
Revised Secs. 814.44(d) and 814.45(d) state that FDA will notify the 
public of PMA approvals and denials by posting them on FDA's home page 
on the Internet at http://www.fda.gov; by placing the summaries of 
safety and effectiveness on the Internet and in FDA's Dockets 
Management Branch; and by publishing in the Federal Register after each 
quarter a list of available safety and effectiveness summaries of 
approved PMA's and denials announced in that quarter.
     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)(3) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 360e(d)(3)), 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 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

[[Page 68696]]

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 following is a list of approved PMA's for which summaries of 
safety and effectiveness were placed on the Internet in accordance with 
the procedure explained previously from July 1, 1999, through September 
30, 1999. 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
      PMA's Made Available July 1, 1999, through September 30, 1999
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  PMA No./Docket
       No.             Applicant         Trade Name       Approval Date
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 P930016(S5)/99M-  Visx, Inc.         Visx Excimer      January 29, 1998
 0293                                  Laser System
                                       Models ``B''
 P970032/99M-2168  BIEX, Inc.         SalEstTM System   April 29, 1998
 P950015/99M-2672  PLC Medical        The Heart         August 20, 1998
                    Systems, Inc.      LaserTM CO2
                                       Laser System
                                       for
                                       Transmyocardial
                                       Revascularizati
                                       on
P980012/99M-2605   Baxter Healthcare  Novacor LVAS            1998
P980035/99M-2671   Medtronic, Inc.    Medtronic         January 29, 1999
                                       KappaTM 700/600
                                       Series Pulse
                                       Generators and
                                       Model 9953
                                       Software
 P970029/99M-2238  Eclipse Surgical   TMR Holmium       February 11,
                    Technologies,      Laser System      1999
                    Inc.
P980031/99M-1167   KeraVision, Inc.   ICRS              April 9, 1999
                                       (Intrastromal
                                       Corneal Ring
                                       Segments)
P970004(S4)/99M-   Medtronic, Inc.    Medtronic         April 15, 1999
 1306                                  Interstim
                                       Contenence
                                       Control System
P970033/99M-1073   TransScan          T-Scan 2000       April 16, 1999
                    Medical, Inc.
P980046/99M-2143   Home Access        Hepatitis C       April 28, 1999
                    Health Corp.       CheckSM/Express
D970003/99M-2606   Guidant Corp.      Guidant PULSARTM/ June 3, 1999
                                       PULSAR MaxTM
P980022/99M-2169   Minimed            Continuous        June 15, 1999
                    Technologies,      Glucose
                    Inc.               Monitoring
                                       System
P970018/99M-2144   AutoCyte, Inc.     AutoCyte Prep     June 17, 1999
                                       System
P950021(S1)/99M-   Bayer Corp.        Bayer Immuno 1TM  June 25, 1999
 2748                                  PSA Assay
P980052/99M-2551   TMJ Concepts       TMJ Concepts      July 2, 1999
                                       Patient-Fitted
                                       TMJ
                                       Reconstruction
                                       Prosthesis
H990004/99M-4134   Nitinol Medical    CardioSEAL        September 8,
                    Technologies,      Septal            1999
                    Inc.               Occlusion
                                       System
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    Dated: November 24, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-31699 Filed 12-7-99; 8:45 am]
BILLING CODE 4160-01-F