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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.
 
DeviceBESTENT 2 WITH DISCRETE TECHNOLOGY(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP000022
Supplement NumberS004
Date Received02/21/2001
Decision Date03/19/2001
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  
OPTION TO USE AN AUTOMATED FILLING AND EVACUATING COATING CHAMBER, THAT THEN AUTOMATICALLY TRANSFERS THE CATHETERS TO THE CURING CHAMBER.
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