|
Device | HANCOCK LOW POROSITY AND MOFIFIED ORIFICE VALVED CONDUIT |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC HEART VALVES 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P790007 |
Supplement Number | S035 |
Date Received | 02/13/2013 |
Decision Date | 03/13/2013 |
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 NEW PORCINE HEART VALVE TISSUE SUPPLIER. |