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(TM) OVER-THE-WIRE AND RAPID EXCHANGE CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P000022 |
Supplement Number | S004 |
Date Received | 02/21/2001 |
Decision Date | 03/19/2001 |
Withdrawal Date
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12/21/2006 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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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