|
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 | S055 |
Date Received | 05/24/2023 |
Decision Date | 11/20/2023 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for various updates to the Instructions for Use: (1) to add the final clinical results of Post-Approval Study #1, Continued Follow-up of the COAPT Trial Pivotal Cohort, ordered in our March 14, 2019, letter; (2) to remove the Anatomic Considerations section; and (3) to add the results of the postmarket EXPAND and EXPAND G4 studies. |