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

FDA premarket approval P100009/S028 · decided 2019-03-14

Approval details

PMA number

P100009

Supplement

S028

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

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

Generic name

Mitral valve repair devices

Applicant

ABBOTT MEDICAL

Date received

2018-11-06

Decision date

2019-03-14

Days to decision

128 days

Decision code

APPR

Product code

NKM

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

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 fr

510(k) clearances by this applicant