|
Device | FREESTYLE AORTIC ROOT BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P970031 |
Supplement Number | S042 |
Date Received | 04/02/2013 |
Decision Date | 09/24/2013 |
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 INSTALLATION OF A NEW REVERSE OSMOSIS, DE-IONIZED WATER SYSTEM. |