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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.
 
Trade NameS7 W/DISCRETE TECHNOLOGY(TM)OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS031
Date Received10/01/2001
Decision Date03/01/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the medtronic ave s7 with discrete technology over-the-wire and rapid exchange coronary stent system labeling to include 6-month post-procedure results for the study population.
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