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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 (TM) 2 WITH DISCRETE TECHNOLOGY OTW/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM
Generic NameSTENT, CORONARY
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP000022
Supplement NumberS007
Date Received08/20/2001
Decision Date09/26/2001
Withdrawal Date 12/21/2006
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AMENDING THE TEST OF THE BESTENT 2 POST-APPROVAL STUDY PROTOCOL TO REFLECT ADMINISTRATIVE UPDATES.
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