PMA P220003S002

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S002
Product code: NKM
Decision date: 2022-11-20
Generic name: Mitral valve repair devices
Approval order statement: 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.

Current openFDA PMA Record#

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S002
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2022-11-20
Decision code: OK30
Date received: 2022-10-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: 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.