|
Device | MitraClip NTR/XTR Clip Delivery System and 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 | S031 |
Date Received | 05/29/2019 |
Decision Date | 07/26/2019 |
Product Code |
NKM |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study entitled "Registry-Based Continued Access Protocol Cohort and Real-World Use Surveillances." |