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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namestent, coronary
Generic Namestent, coronary
parkmore business park west
PMA NumberP970035
Supplement NumberS015
Date Received04/26/1999
Decision Date11/23/1999
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number N
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The device is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length <30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 and 4.0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present. The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressue during the 15-30 second stent deployment procedure only. The rapid exchange stent delivery system is not intended for use as a stand alone PTCA perfusion catheter.