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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 NameS670 W/DISCRETE TECHNOLOGY(TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS039
Date Received04/24/2002
Decision Date04/17/2003
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to update the labeling of the s670 with discrete technology over-the-wire and rapid exchange coronary stent systems to include post-procedure results for the predict study population and remove references to the european racecar study.
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