|
Device | MitraClip™ G4 Clip Delivery System |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Supplement Number | S045 |
Date Received | 01/31/2022 |
Decision Date | 08/08/2022 |
Product Code |
NKM |
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 the addition of a manufacturing site located at 1820 Bastian Court, Westfield, Indiana, 46074. |