|
Device | BIOCOR VALVE AND BIOCOR SUPRA VALVE\ |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P040021 |
Supplement Number | S006 |
Date Received | 03/12/2008 |
Decision Date | 05/06/2008 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY. |