[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