|
Device | HANCOCK MODIFIED ORIFICE VALVED CONDUIT MODEL 150 |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC HEART VALVES 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P790007 |
Supplement Number | S032 |
Date Received | 03/23/2012 |
Decision Date | 01/10/2013 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE GLUTARALDEHYDE STOCK SOLUTION THAT IS OBTAINED FROM DOWCHEMICAL FOR THE FIXATIVE, STORAGE, AND STERILIZATION SOLUTIONS TO BE CHANGED FROM A 25% STOCK SOLUTION TO A 50% STOCK SOLUTION. |