Atlas FDA

PASCAL Precision Transcatheter Valve Repair System

FDA premarket approval P220003 · decided 2022-09-14

Approval details

PMA number
P220003
Trade name
PASCAL Precision Transcatheter Valve Repair System
Generic name
Mitral valve repair devices
Applicant
Edwards Lifesciences, LLC
Date received
2022-03-14
Decision date
2022-09-14
Days to decision
184 days
Decision code
APPR
Product code
NKM
Advisory committee
Cardiovascular
Expedited review
No
Location
Irvine, CA
Statement
Approval for the PASCAL Precision Transcatheter Valve Repair System. This device is indicated for the percutaneous reduction of significant, 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 exis

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510(k) clearances by this applicant

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