PMA P140031S209

Device: Edwards Crimper (9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26, 9750CM29)
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S209
Product code: NPT
Decision date: 2026-09-23
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: adoption of the Edwards Crimper into an existing validated sterilization cycle

Current openFDA PMA Record#

Device: Edwards Crimper (9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26, 9750CM29)
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S209
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-09-23
Decision code: OK30
Date received: 2026-08-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: adoption of the Edwards Crimper into an existing validated sterilization cycle