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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS028
Date Received11/06/2018
Decision Date03/14/2019
Product Code NKM 
Docket Number 19M-1251
Notice Date 03/19/2019
Advisory Committee Cardiovascular
Clinical TrialsNCT01626079
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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