|
Device | FREESTYLE AORTIC ROOT BIOPROSTHESIS, MODELS 995, 995MS AND 995CS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S014 |
Date Received | 12/27/2005 |
Decision Date | 04/20/2006 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE IMPLEMENTATION OF SMALLER CAPACITY EQUIPMENT AND ELIMINATION OF THE SHRINK TEMPERATURE TESTING USED FOR THE TISSUE FIXATION MANUFACTURING PROCESS. |