|
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 | S011 |
Date Received | 08/16/2013 |
Decision Date | 01/16/2014 |
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 FOR A CHANGE TO THE STENT SUB-ASSEMBLY CLEANING PROCESS THAT OCCURS PRIOR TO THE ELECTROPOLISH PROCESS. |