PMA P200015S010

Device: Edwards Commander Delivery System, Crimper
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S010
Product code: NPV
Decision date: 2021-06-29
Generic name: Pulmonary valve prosthesis percutaneously delivered
Approval order statement: Approval for a manufacturing site located at Edwards Lifesciences Technology SARL, Hwy #402 N Km 1.4, Añasco, Puerto Rico for ethylene oxide (EO) sterilization of the Commander Delivery System and Crimper accessory for the SAPIEN 3 Transcatheter Heart Valve System.

Current openFDA PMA Record#

Device: Edwards Commander Delivery System, Crimper
Applicant: Edwards Lifesciences, LLC
PMA number: P200015
Supplement: S010
Product code: NPV
Generic name: Pulmonary valve prosthesis percutaneously delivered
Decision date: 2021-06-29
Decision code: APPR
Date received: 2021-06-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Edwards Lifesciences Technology SARL, Hwy #402 N Km 1.4, Añasco, Puerto Rico for ethylene oxide (EO) sterilization of the Commander Delivery System and Crimper accessory for the SAPIEN 3 Transcatheter Heart Valve System.