PMA P220003S021

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S021
Product code: NKM
Decision date: 2024-11-07
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: Approval for various updates to the device preparation steps related to the de-airing process in the Instructions for Use.

Current openFDA PMA Record#

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S021
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2024-11-07
Decision code: APPR
Date received: 2024-10-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for various updates to the device preparation steps related to the de-airing process in the Instructions for Use.