|
Device | IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) 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 | S039 |
Date Received | 03/19/2018 |
Decision Date | 05/25/2018 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the 200 mm and 250 mm balloon lengths for the IN.PACT Admiral Paclitaxel-Coated Percutaneous-Transluminal Angioplasty Balloon Catheter. |