MITRACLIP DELIVERY SYSTEM

FDA premarket approval P100009 · decided 2013-10-24

Approval details

PMA number

P100009

Trade name

MITRACLIP DELIVERY SYSTEM

Generic name

Mitral valve repair devices

Applicant

ABBOTT MEDICAL

Date received

2010-03-04

Decision date

2013-10-24

Days to decision

1330 days

Decision code

APPR

Product code

NKM

Advisory committee

Cardiovascular

Expedited review

Yes

Location

St. Paul, MN

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 C

510(k) clearances by this applicant