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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/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP000022
Supplement NumberS008
Date Received09/07/2001
Decision Date10/02/2001
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 
Change in the manufacturing process of joining the two types of tubing to a process where the jacket is extruded directly onto the hypotube.
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