PMA P100009S028

Device

MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System

Applicant

ABBOTT MEDICAL

PMA number

P100009

Supplement

S028

Product code

NKM

Decision date

2019-03-14

Classification

Mitral Valve Repair Devices

Generic name

Mitral valve repair devices

Approval order statement

Approval for the MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System for expanding the indication to include secondary mitral regurgitation. The devices, when used with maximally tolerated guideline-directed medical therapy (GDMT), are indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR >= Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) >= 20% and <= 50%, and a left ventricular end systolic dimension (LVESD) <= 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.

Summary

<a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100009S028B.pdf" target="_new">Summary of Safety and Effectiveness</a>