|
Device | EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | MEDTRONIC VASCULAR INC 3033 Campus Drive Plymouth, MN 55441 |
PMA Number | P110023 |
Supplement Number | S002 |
Date Received | 05/16/2012 |
Decision Date | 06/14/2012 |
Product Code |
NIP |
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 REDUCTION OF THE UV INTENSITY USED TO CURE THE BONDING ADHESIVE OF THE MANIFOLD SUB- ASSEMBLY PROCESS. |