|
Device | FREESTYLE AORTIC ROOT BIOPROTHESIS MODEL 995 |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S015 |
Date Received | 03/27/2006 |
Decision Date | 08/28/2006 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE INSTRUCTIONS FOR USE (IFU) BASED ON THE RESULTS OF THE COMPLETED POST-MARKET STUDY FOR THE DEVICE. |