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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 NameS660TM WITH DISCRETE TECHNOLOGY OVER-THE-WIRE CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantARTERIAL VASCULAR ENGINEERING, INC.
PMA NumberP970035
Supplement NumberS017
Date Received08/24/1999
Decision Date05/09/2000
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 medtronic ave (ave) s660 with discrete technology over-the-wire and rapid exchange coronary stent systems.
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