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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 OTW/RX CORONARY STENT DELIVERY SYSTEMS
Generic NameSTENT, CORONARY
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP000022
Supplement NumberS006
Date Received04/16/2001
Decision Date06/05/2001
Withdrawal Date12/21/2006
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE UPDATED LABELING FOR THE BESTENT(TM) 2 WITH DISCRETE TECHNOLOGY(TM) RAPID EXCHANGE AND OVER-THE-WIRE CORONARY STENT DELIVERY SYSTEMS.
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