|
Device | FREESTYLE AORTIC ROOT BIOPROSTHESIS MODELS 995/995CS/995MS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S030 |
Date Received | 10/20/2010 |
Decision Date | 11/19/2010 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A QUALITY CONTROL TEST FOR AN INCOMING RAW MATERIAL. |