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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 (TM) OTW/RAPID EXCHANGE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS029
Date Received08/14/2001
Decision Date10/04/2001
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
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 (rx) coronary stent systems using the av100 balloon material. (note that although this material was included in product used in the clinical trial reported in supplement 22, approval was only sought and granted for the av2000 balloon material. ).
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