PASCAL Precision Transcatheter Valve Repair System

FDA Premarket Approval P220003 S002

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.

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 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-18
Decision Date2022-11-20
PMAP220003
SupplementS002
Product CodeNKM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressEdwards LifeSciences LLC
one Edwards Way
irvine, CA 92614 PMA NumberP220003 Supplement NumberS002 Date Received10/18/2022 Decision Date11/20/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Implement A Custom Automated Vision System For Part Detection On The Packaging Card During The Pouch Packaging And Inspection Process For The PASCAL Precision Implant Systems

Supplemental Filings

Supplement NumberDateSupplement Type
P220003Original Filing
S002 2022-10-18 30-day Notice
S001 2022-10-12 30-day Notice

NIH GUDID Devices

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

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