PMA P220003S005

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S005
Product code: NKM
Decision date: 2022-12-20
Generic name: Mitral valve repair devices
Approval order statement: Update to the in-process visual inspection criteria for flash in the suture lumens and center lumen of the shaft component during the manufacturing of the Implant Catheter.

Current openFDA PMA Record#

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S005
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2022-12-20
Decision code: OK30
Date received: 2022-12-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update to the in-process visual inspection criteria for flash in the suture lumens and center lumen of the shaft component during the manufacturing of the Implant Catheter.