|
Device | MITRACLIP DELIVERY SYSTEM |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 Country Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Date Received | 03/04/2010 |
Decision Date | 10/24/2013 |
Product Code |
NKM |
Docket Number | 13M-1365 |
Notice Date | 11/15/2013 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00209274
|
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MITRACLIP CLIP DELIVERY SYSTEM (MITRACLIP CDS). THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS REDUCTION OFSIGNIFICANT SYMPTOMATIC MITRAL REGURGITATION (MR >= 3+) DUE TO PRIMARY ABNORMALITY OF THE MITRAL APPARATUS [DEGENERATIVE MR] IN PATIENTS WHO HAVE BEEN DETERMINED TO BE AT PROHIBITIVE RISK FOR MITRAL VALVE SURGERY BY A HEART TEAM, WHICH INCLUDES A CARDIAC SURGEON EXPERIENCED IN MITRAL VALVE SURGERY AND A CARDIOLOGIST EXPERIENCED IN MITRAL VALVE DISEASE, AND IN WHOM EXISTING COMORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM REDUCTION OF THE MITRAL REGURGITATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S007 S014 S015 S016 S001 S002 S004 S005 S012 S018 S019 S022 S023 S006 S008 S009 S013 S010 S011 S017 S020 S021 S024 S025 S030 S031 S034 S035 S036 S028 S042 S050 S051 S044 S054 S058 S059 S026 S027 S029 S037 S032 S033 S047 S048 S045 S055 S056 S052 S053 S038 S039 S049 S046 S043 S063 S064 S057 S060 S061 S062 |