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. |
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Device | BESTENT 2 WITH DISCRETE TECHNOLOGY OTW/RX CORONARY STENT DELIVERY SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P000022 |
Supplement Number | S006 |
Date Received | 04/16/2001 |
Decision Date | 06/05/2001 |
Withdrawal Date
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12/21/2006 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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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