|
Device | ST. JUDE MEDICAL 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 | S001 |
Date Received | 09/06/2005 |
Decision Date | 08/03/2006 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE. |