[Federal Register Volume 59, Number 75 (Tuesday, April 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-9355]


[[Page Unknown]]

[Federal Register: April 19, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0065]

 

Leocor, Inc.; Premarket Approval of CorfloTM Models 5S, 
7.5S, and 7.5PT PTCA Catheter and 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 supplemental application by Leocor, Inc., Houston, TX, 
for premarket approval, under section 515 of the Federal Food, Drug, 
and Cosmetic Act (the act), of the CorfloTM Models 5S, 7.5S, and 
7.5PT PTCA Catheter and Hemoperfusion Pump. 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 February 15, 1994, of the approval of the supplemental 
application.

DATES: Petitions for administrative review by May 19, 1994.

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: Tara A. Ryan, Center for Devices and 
Radiological Health (HFZ-450), Food and Drug Administration, 1390 
Piccard Dr., Rockville, MD 20850, 301-594-1197.

SUPPLEMENTARY INFORMATION: On December 3, 1990, Leocor, Inc., Houston, 
TX, 77058, submitted to CDRH a supplemental application for premarket 
approval of the CorfloTM Models 5S, 7.5S, and 7.5PT PTCA Catheter 
and Hemoperfusion Pump. The device is indicated as follows:
    Percutaneous transluminal coronary angioplasty (PTCA) can be 
indicated by the physician 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:
     Single or multiple vessel atherosclerotic coronary 
artery disease that is concentric and accessible to a dilation 
catheter.
     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.
    On June 4, 1991, the Circulatory System Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the supplemental application. On February 
15, 1994, CDRH approved the supplemental application by a letter to the 
applicant from the Acting 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 (21 
U.S.C. 360e(g)), 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 May 19, 1994, 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 Center for Devices and Radiological Health (21 
CFR 5.53).

    Dated: April 5, 1994.
 Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 94-9355 Filed 4-18-94; 8:45 am]
BILLING CODE 4160-01-F