|
Device | In.Pact Admiral Paclitaxel-coated 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 | S047 |
Date Received | 08/30/2019 |
Decision Date | 09/13/2019 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement updates to your device labeling |