|
Device | SJM BIOCOR AND EPIC 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 | S027 |
Date Received | 12/30/2015 |
Decision Date | 10/14/2016 |
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 | No |
Approval Order Statement Approval for the replacement of a cleaning detergent used in the manufacturing of Biocor and Epic valves. |