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 | S7/S670/S660/BESTENT 2/ WITH DISCRETE TECHNOLOGY RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | Medtronic Vascular 3576 Unocal Place Santa Rosa, CA 95403 |
PMA Number | P000022 |
Supplement Number | S008 |
Date Received | 09/07/2001 |
Decision Date | 10/02/2001 |
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 CHANGE IN THE MANUFACTURING PROCESS OF JOINING THE TWO TYPES OF TUBING TO A PROCESS WHERE THE JACKET IS EXTRUDED DIRECTLY ONTO THE HYPOTUBE. |
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