PMA P220003S025

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S025
Product code: NKM
Decision date: 2025-09-09
Classification: Cardiovascular
Generic name: Mitral valve repair devices
Approval order statement: to reduce the receiving inspection levels for a component of the PASCAL Ace implant from 100% inspection to Lot Tolerance Percent Defective (LTPD)-based sampling

Current openFDA PMA Record#

Device: PASCAL Precision Transcatheter Valve Repair System
Applicant: Edwards Lifesciences, LLC
PMA number: P220003
Supplement: S025
Product code: NKM
Generic name: Mitral valve repair devices
Decision date: 2025-09-09
Decision code: OK30
Date received: 2025-08-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to reduce the receiving inspection levels for a component of the PASCAL Ace implant from 100% inspection to Lot Tolerance Percent Defective (LTPD)-based sampling