|
Device | MitraClip System (NTR and XTR) |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Supplement Number | S030 |
Date Received | 05/03/2019 |
Decision Date | 06/03/2019 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an update to the Instructions for Use to clarify correct device use. |