Mitraclip Delivery System
FDA premarket approval P100009 · Mitral valve repair devices
PMA numberP100009
Approval
- Applicant
- Abbott Medical
- Received
- March 4, 2010
- Decision date
- October 24, 2013 (APPR)
- Supplements
- 82, latest June 25, 2026
- Product code
- NKM – Mitral Valve Repair Devices
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.