PMA P140031S190

Device: Edwards Commander Delivery System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S190
Product code: NPT
Decision date: 2025-06-26
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: to modify a specification used by the equipment when producing the braid component of the Commander Delivery System Balloon Shaft subassembly

Current openFDA PMA Record#

Device: Edwards Commander Delivery System
Applicant: Edwards Lifesciences, LLC
PMA number: P140031
Supplement: S190
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2025-06-26
Decision code: OK30
Date received: 2025-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to modify a specification used by the equipment when producing the braid component of the Commander Delivery System Balloon Shaft subassembly