PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)

FDA Premarket Approval P220003 S001

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 – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)
Generic NameMitral Valve Repair Devices
ApplicantEdwards LifeSciences LLCone Edwards Wayirvine, CA 92614 PMA NumberP220003 Supplement NumberS001 Date Received10/12/2022 Decision Date10/19/2022 Product Code NKM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-12
Decision Date2022-10-19
PMAP220003
SupplementS001
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 NumberS001 Date Received10/12/2022 Decision Date10/19/2022 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  
a Change In Yarn Extruder And An Additional Bias Cloth Manufacturing Step

Supplemental Filings

Supplement NumberDateSupplement Type
P220003Original Filing
S005 2022-12-19 30-day Notice
S004 2022-11-15 30-day Notice
S003 2022-11-07 30-day Notice
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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