|
Device | MitraClip NT, NTR, XTR, 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 | S034 |
Date Received | 08/06/2019 |
Decision Date | 08/30/2019 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for manufacturing process changes to reduce Clip Arm spread variability and to implement an inspection for final Clip Arm spread. |