|
Device | MITRACLIP CLIP DELIVERY SYSTEM; MITRACLIP STEERABLE GUIDE CATHETER |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Supplement Number | S012 |
Date Received | 05/04/2015 |
Decision Date | 07/23/2015 |
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 TO ADD A ONE-WAY ACTUATOR TO THE MITRACLIP DELIVERY SYSTEM CATHETER HANDLE. |