PMA P140031S144

Device: Edwards SAPIEN 3™ Transcatheter Heart Valve and Edwards SAPIEN 3™ Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S144
Product code: NPT
Decision date: 2022-09-23
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Implementation of an enhanced temperature indicator packaging component to monitor surgical and transcatheter heart valves during transit and storage.

Current openFDA PMA Record#

Device: Edwards SAPIEN 3™ Transcatheter Heart Valve and Edwards SAPIEN 3™ Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S144
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2022-09-23
Decision code: OK30
Date received: 2022-08-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an enhanced temperature indicator packaging component to monitor surgical and transcatheter heart valves during transit and storage.