|
Device | ST JUDE MEDICAL BIOCOR/BIOCOR/SUPRA/EPIC/EPIC SUPRA HEART VALVES |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P040021 |
Supplement Number | S016 |
Date Received | 01/06/2011 |
Decision Date | 12/22/2011 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL STERILIZATION SITE AND FOR FINAL PACKAGING OPERATIONS LOCATED AT ST. JUDE MEDICAL, PAMPULHA, BRAZIL. |