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

• Device: PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)
• Generic Name: Mitral Valve Repair Devices
• Applicant: Edwards 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 Received: 2022-10-12
• Decision Date: 2022-10-19
• PMA: P220003
• Supplement: S001
• Product Code: NKM
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Edwards 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 Number	Date	Supplement Type
P220003		Original 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 ID	PMA	Supp
00690103216981	P220003	000
00690103216974	P220003	000
00690103216967	P220003	000
00690103216950	P220003	000
00690103216943	P220003	000