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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/S660/BESTENT(TM)2/WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP970035
Supplement NumberS023
Date Received11/24/2000
Decision Date12/19/2000
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 bonding process change for conversion bonds and jacket bonds.
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