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 | RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040012 |
Supplement Number | S006 |
Date Received | 02/24/2006 |
Decision Date | 03/24/2006 |
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 REMOVAL OF THE OPTION OF USING ISOPROPYL ALCOHOL (IPA) AND A DRY WIPE FOR REMOVING PARTICULATES PRIOR TO LOADING THE STENT ON THE DELIVERY SYSTEM. |
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