|
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 | S061 |
Date Received | 10/24/2023 |
Decision Date | 01/22/2024 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement • Change in the polyester yarn supplier of the Clip Cover• Change in raw material sub-supplier and source of Polypropylene resin material for the Cover reinforcement material• Change in the incoming quality inspection tolerance for a Clip Arm dimension, and• Change in the Stomper equipment setup control range. |