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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 Namecardiovascular stent
PMA NumberP970035
Supplement NumberS022
Date Received10/20/2000
Decision Date04/04/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the s7 with discrete technology(tm) over-the-wire (otw) and rapid exchange (rz) coronary stent systems. The devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo lesions (length <= 30 mm) in native coronary arteries with reference vessel diameters ranging from 3. 0 mm and 4. 0 mm. Long term outcome (beyond 14 days) for this permanent implant is unknown at present. The rx relivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure 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.