[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37067-37068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17975]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0166]


Johnson and Johnson Interventional Systems Co.; Premarket 
Approval of PALMAZ-SCHATZTM Balloon-Expandable Stent

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Johnson and Johnson Interventional 
Systems Co., Warren, NJ, for premarket approval, under the Federal 
Food, Drug, and Cosmetic Act (the act), of PALMAZ-SCHATZTM 
Balloon-Expandable Stent. After reviewing the recommendation of the 
Circulatory System Devices Panel, FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of August 
2, 1994, of the approval of the application. In addition, the PALMAZ-
SCHATZTM Balloon-Expandable Stent requires tracking under 
the act as amended by the Safe Medical Devices Act of 1990.

DATES: Petitions for administrative review by August 11, 1997.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Bram D. Zuckerman, Center for Devices 
and Radiological Health (HFZ-450),

[[Page 37068]]

Food and Drug Administration, 1390 Piccard Dr., Rockville, MD 20850, 
301-443-8243.

SUPPLEMENTARY INFORMATION: On December 7, 1990, Johnson and Johnson 
Interventional Systems, Co., Warren, NJ 07059, submitted to CDRH an 
application for premarket approval of PALMAZ-SCHATZTM 
Balloon-Expandable Stent. The PALMAZ-SCHATZTM Balloon-
Expandable Stent is indicated for use in a group of selected patients 
eligible for balloon angioplasty (see Individualization of Treatment, 
which is available for examination at the Dockets Management Branch 
(address above)) with symptomatic ischemic heart disease due to 
discrete (length less than 15 millimeter (mm)), de novo native coronary 
artery lesions with a reference vessel diameter in the range of 3 to 4 
mm. In this patient population, stenting the coronary artery produces a 
larger luminal diameter, maintains arterial patency, and reduces the 
incidence of restenosis at 6 months as compared with balloon 
angioplasty. The stent, however, represents a permanent implant into 
the coronary artery. One year and longer followup is not well 
characterized.
    On May 3, 1994, the Circulatory System Devices Panel of the Medical 
Devices Advisory Committee, an FDA advisory committee, reviewed and 
recommended approval of the application.
    On August 2, 1994, CDRH approved the application by a letter to the 
applicant from the Director of the Office of Device Evaluation, CDRH.
    A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

Opportunity for Administrative Review

    Section 515(d)(3) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360e(d)(3)) authorizes any interested person to 
petition, under section 515(g) of the act, for administrative review of 
CDRH's decision to approve this application. A petitioner may request 
either a formal hearing under 21 CFR part 12 of FDA's administrative 
practices and procedures regulations or a review of the application and 
CDRH's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
21 CFR 10.33(b). A petitioner shall identify the form of review 
requested (hearing or independent advisory committee) and shall submit 
with the petition supporting data and information showing that there is 
a genuine and substantial issue of material fact for resolution through 
administrative review. After reviewing the petition, FDA will decide 
whether to grant or deny the petition and will publish a notice of its 
decision in the Federal Register. If FDA grants the petition, the 
notice will state the issue to be reviewed, the form of the review to 
be used, the persons who may participate in the review, the time and 
place where the review will occur, and other details.
    Petitioners may, at any time on or before August 11, 1997 file with 
the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: May 29, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-17975 Filed 7-9-97; 8:45 am]
BILLING CODE 4160-01-F