PMA P140031

Device: Edwards Crimper: 9600CR
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S151
Product code: NPT
Decision date: 2026-07-17
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for two manufacturing sites located at the Edwards Limerick Facility and at Sterigenics Belgium for production and sterilization of the Edwards Crimper, respectively.

Current openFDA PMA Record#

Device: Edwards Crimper: 9600CR
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S192
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-07-17
Decision code: APPR
Date received: 2025-08-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for two manufacturing sites located at the Edwards Limerick Facility and at Sterigenics Belgium for production and sterilization of the Edwards Crimper, respectively.