|
Device | IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | MEDTRONIC Inc. 3576 UNOCAL PL SANTA ROSA, CA 95403 |
PMA Number | P140010 |
Supplement Number | S018 |
Date Received | 05/25/2016 |
Decision Date | 10/31/2016 |
Product Code |
ONU |
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 | Yes |
Approval Order Statement Approval for modifications to the potency and related substances test method to include relative retention time and correction factors. |