|
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 | S016 |
Date Received | 04/07/2015 |
Decision Date | 07/30/2015 |
Product Code |
NIO |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MANUFACTURE A COMPONENT OF THE CATHETER IN-HOUSE. |