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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 NameS660 OVER THE WIRE CORONARY STENT SYSTEM, S660 ZIPPER MX CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC AVE, INC.
PMA NumberP970035
Supplement NumberS046
Date Received01/17/2006
Decision Date02/01/2006
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Manufacturing process change to eliminate the post-annealing metallography inspection.
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