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 | MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID SYSTEM |
Generic Name | STENT, CAROTID |
Applicant | Medtronic Vascular 3576 UNOCAL PLACE SANTA ROSA, CA 95403-1774 |
PMA Number | P070012 |
Supplement Number | S001 |
Date Received | 02/04/2008 |
Decision Date | 03/06/2008 |
Withdrawal Date
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09/20/2013 |
Product Code |
NIM |
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 BY THE VENDOR OF THE EXPONENT RX PACKAGING HEADER POUCH TO THE EQUIPMENT USED TO PRODUCE THE VENDOR-SUPPLIED SEALS. |
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