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 | S001 |
Date Received | 05/11/2012 |
Decision Date | 06/07/2012 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE EXTRUDED TUBING PROCESS. |
|
|