|
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 | S011 |
Date Received | 10/28/2015 |
Decision Date | 11/23/2015 |
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 THE USE OF AN ELECTRONIC SYSTEM AS AN ALTERNATE TO A PAPER-BASED SYSTEM FOR DETERMINING AND CONTROLLING MASTER LOT RECORDS (MLRS) AND SAMPLING BATCHES OR MLRS FOR THE PURPOSE OF LOT RELEASE TESTING. |