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Device | MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR 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 | S049 |
Date Received | 11/09/2022 |
Decision Date | 11/20/2022 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Modify the flexural rigidity acceptance criteria for the MitraClip delivery catheter shaft component. |