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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceS670/S660/BESTENT(TM)2 WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP000022
Supplement NumberS003
Date Received11/24/2000
Decision Date12/19/2000
Withdrawal Date12/21/2006
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING BONDING PROCESS CHANGE FOR CONVERSION BONDS AND JACKET BONDS.
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