|
Device | SJM BIOCOR VALVE AND SJM 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 | S003 |
Date Received | 08/07/2006 |
Decision Date | 05/25/2007 |
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 ADDITION OF THE 29MM BIOCOR AORTIC VALVE; ADDITION OF SIZES 25MM AND 27MM BICOR SUPRA AORTIC VALVE; A CHANGE IN THE PACKAGE SOLUTION CONCENTRATION; A REDUCED PRE-IMPLANT RINSE TIME; A CHANGE IN THE VALE HOLDER AND HOLDER HANDLE DESIGNS; AND ADDITIONAL HEMODYNAMIC DATA FOR THE 27MM BIOCOR MITRAL VALVE. |