PMA P150036S019

Device: EDWARDS INTUITY Elite Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P150036
Supplement: S019
Product code: LWR
Decision date: 2018-01-30
Classification: Heart-valve, Non-allograft Tissue
Generic name: heart-valve, non-allograft tissue
Approval order statement: Approval for the addition of a new modular cleanroom for surgical heart valve stent sub-assemblies in the Cartago, Costa Rica facility.

Current openFDA PMA Record#

Device: EDWARDS INTUITY Elite Valve System
Applicant: Edwards Lifesciences, LLC
PMA number: P150036
Supplement: S019
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2018-01-30
Decision code: APPR
Date received: 2017-09-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of a new modular cleanroom for surgical heart valve stent sub-assemblies in the Cartago, Costa Rica facility.