|
Device | IN.PACT™ Admiral™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) 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 | S074 |
Date Received | 08/10/2023 |
Decision Date | 09/22/2023 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for a labeling update to include the long-term data from the IN.PACT Admiral DCB In-stent Restenosis (ISR) Post-market Registry. |