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. |
|
Device | XACT Carotid Stent System |
Generic Name | STENT, CAROTID |
Applicant | ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
PMA Number | P040038 |
Supplement Number | S038 |
Date Received | 10/29/2021 |
Decision Date | 11/24/2021 |
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 Modifications to the equipment and processes used for laser cutting, microblasting, electropolishing, and cleaning of the stent subcomponent. |
|
|