PASCAL Precision Transcatheter Valve Repair System 510(k) FDA Approval

Device	PASCAL Precision Transcatheter Valve Repair System
Generic Name	Mitral Valve Repair Devices
Applicant	Edwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Date Received03/14/2022 Decision Date09/14/2022 Product Code NKM Advisory Committee Cardiovascular Clinical TrialsNCT03706833 Expedited Review Granted? No
Date Received	2022-03-14
Decision Date	2022-09-14
PMA	P220003
Supplement	S
Product Code	NKM
Advisory Committee	Cardiovascular
Expedited Review	No
Combination Product	No
Applicant Address	Edwards LifeSciences LLC one Edwards Way irvine, CA 92614 PMA NumberP220003 Date Received03/14/2022 Decision Date09/14/2022 Product Code NKM Advisory Committee Cardiovascular Clinical TrialsNCT03706833 Expedited Review Granted? No Combination ProductNo Approval Order 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 Existing Comorbidities Would Not Preclude The Expected Benefit From Reduction Of The MR. Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling Labeling Part 2 Supplements:

PASCAL Precision Transcatheter Valve Repair System