|
Device | MISAGO RX SELF-EXPANDING PERIPHERAL STENT |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | TERUMO MEDICAL CORPORATION 950 ELKTON BLVD ELKTON, MD 21921 |
PMA Number | P140002 |
Supplement Number | S001 |
Date Received | 05/26/2015 |
Decision Date | 06/24/2015 |
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 MODIFICATIONS TO THE DELIVERY SYSTEM, CHANGE TO TWO OF THE SUBCOMPONENTS OF THE DELIVERY CATHETER COMPONENT. |