PASCAL Precision Transcatheter Valve Repair System

FDA Premarket Approval P220003

Pre-market Approval Supplement Details

DevicePASCAL Precision Transcatheter Valve Repair System
Generic NameMitral Valve Repair Devices
ApplicantEdwards 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 Received2022-03-14
Decision Date2022-09-14
PMAP220003
SupplementS
Product CodeNKM 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination ProductNo
Applicant AddressEdwards 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:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P220003Original Filing

NIH GUDID Devices

Device IDPMASupp
00690103216981 P220003 000
00690103216974 P220003 000
00690103216967 P220003 000
00690103216950 P220003 000
00690103216943 P220003 000

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