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 | Absolute Pro Vascular Self-Expanding Stent System |
Generic Name | STENT, ILIAC |
Applicant | ABBOTT VASCULAR INC. 3200 LAKESIDE DRIVE SANTA CLARA, CA 92054 |
PMA Number | P110028 |
Supplement Number | S021 |
Date Received | 08/05/2020 |
Decision Date | 08/28/2020 |
Product Code |
NIO |
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 Adding automated tab welding equipment and modifying tab weld geometry. |
|
|