PMA P220003S020

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S020
Product code: NKM
Decision date: 2024-10-29
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: to repurpose an existing cleanroom with processes performed in an existing cleanroom in addition to an increase in the allowable personnel limit

Current openFDA PMA Record#

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S020
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2024-10-29
Decision code: OK30
Date received: 2024-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to repurpose an existing cleanroom with processes performed in an existing cleanroom in addition to an increase in the allowable personnel limit