|
Device | MITRACLIP 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 | S018 |
Date Received | 05/11/2016 |
Decision Date | 08/09/2016 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design change to the Actuator Slider component of the delivery system. |