|
Device | IN.Pact Admiral Paclitaxel-Coated Ballon Catheter |
Generic Name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Applicant | MEDTRONIC Inc. 3576 UNOCAL PL SANTA ROSA, CA 95403 |
PMA Number | P140010 |
Supplement Number | S034 |
Date Received | 06/13/2017 |
Decision Date | 06/23/2017 |
Product Code |
ONU |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Use of a new fixture for proximal connector tube flaring. |