[Federal Register Volume 59, Number 240 (Thursday, December 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30867]


[[Page Unknown]]

[Federal Register: December 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0403]

 

SCIMED, Inc.; Premarket Approval of the SCIMED Percutaneous 
Transluminal Coronary Angioplasty (PTCA) Catheter and CorfloTM 
Hemoperfusion Pump

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 Scimed Life Systems, Inc., Maple Grove, 
MN, for premarket approval, under the Federal Food, Drug, and Cosmetic 
Act (the act), of the SCIMED Percutaneous Transluminal Coronary 
Angioplasty (PTCA) Catheter and CorfloTM Hemoperfusion Pump. These 
devices are to be manufactured under an agreement with Leocor, Inc., 
Houston, TX, which has authorized Scimed Life Systems, Inc., to 
incorporate information contained in its approved premarket approval 
application (PMA) and related supplements for the Leocor PTCA Catheter 
and CorfloTM Hemoperfusion Pump. FDA's Center for Devices and 
Radiological Health (CDRH) notified the applicant, by letter of 
September 28, 1994, of the approval of the application.

DATES: Petitions for administrative review by January 17, 1995.

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, rm. 
1-23, 12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Glenn N. Byrd, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8243.

SUPPLEMENTARY INFORMATION: On February 18, 1994, Scimed Life Systems, 
Inc., Maple Grove, MN 55311-3648, submitted to CDRH an application for 
premarket approval of the SCIMED PTCA Catheter and CorfloTM 
Hemoperfusion Pump. These devices are indicated for PTCA in patients 
with significant coronary artery disease who are acceptable candidates 
for coronary artery bypass graft surgery and who meet one of the 
following selection criteria: (1) Single or multiple vessel 
atherosclerotic coronary artery disease that is accessible to a 
dilatation catheter, or (2) coronary artery disease of the native 
coronary arteries and/or coronary artery bypass grafts of some patients 
who have previously undergone coronary artery bypass graft surgery and 
who have recurrence of symptoms and (a) progression of disease or (b) 
stenosis and closure of the grafts. Hemoperfusion can be indicated by 
the physician in patients who cannot tolerate the inflation times 
necessary to achieve the desired stenosis reduction. Intolerance to 
inflation is demonstrated by anginal pain and/or ST segment elevation, 
and/or hemodynamic instability (systemic blood pressure drop) and/or 
arrhythmias. The application includes authorization from Leocor, Inc., 
Houston, TX, to incorporate information contained in its approved PMA 
and related supplements for the SCIMED PTCA Catheter and CorfloTM 
Hemoperfusion Pump. In accordance with the provisions of section 
515(c)(2) of the act as amended by the Safe Medical Devices Act of 
1990, this PMA was not referred to the Circulatory System Devices 
Panel, an FDA advisory panel, for review and recommendation because the 
information in the PMA substantially duplicates information previously 
reviewed by this panel.
    On September 28, 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 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 part 12 (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 Sec. 10.33(b) (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 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 January 17, 1995, 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: December 5, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-30867 Filed 12-14-94; 8:45 am]
BILLING CODE 4160-01-F