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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 WITH DISCRETE TECHNOLOGY OVER THE WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS033
Date Received12/26/2001
Decision Date04/24/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of an optional mechanical fixation step to the stent securement process. The device, as modified, will be marketed under the trade name s7 with discrete technology over-the-wire coronary stent system and is indicated for the improvement of coronary luminal diameter.
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