|
Device | TRIFECTA VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P100029 |
Supplement Number | S015 |
Date Received | 05/28/2013 |
Decision Date | 05/08/2014 |
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 | Yes |
Approval Order Statement APPROVAL FOR AN ALTERNATE BACTERIAL ENDOTOXIN SAMPLING/TESTING PLAN FOR THE TRIFECTA VALVE. |