|
Device | MitraClip™ NTR/XTR Clip Delivery System, 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 | S059 |
Date Received | 09/18/2023 |
Decision Date | 10/17/2023 |
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 a material change for a component of the MitraClip delivery system |