PMA P230013S008

Device: EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S008
Product code: NPW
Decision date: 2024-08-07
Classification: Cardiovascular
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Approval order statement: to change the receiving inspection of components from 100% inspection to a Lot Tolerance Percent Defective (LTPD) basis and to remove redundant in-process measurement of tissue thickness

Current openFDA PMA Record#

Device: EVOQUE Tricuspid Valve Replacement System
Applicant: Edwards Lifesciences, LLC
PMA number: P230013
Supplement: S008
Product code: NPW
Generic name: Percutaneously Delivered Prostheses and Tricuspid Valves
Decision date: 2024-08-07
Decision code: OK30
Date received: 2024-07-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to change the receiving inspection of components from 100% inspection to a Lot Tolerance Percent Defective (LTPD) basis and to remove redundant in-process measurement of tissue thickness