PMA P130009S108

Device: Edwards SAPIEN XT Transcatheter Heart Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P130009
Supplement: S108
Product code: NPT
Decision date: 2020-03-05
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.

Current openFDA PMA Record#

Device: Edwards SAPIEN XT Transcatheter Heart Valve
Applicant: Edwards Lifesciences, LLC
PMA number: P130009
Supplement: S108
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2020-03-05
Decision code: OK30
Date received: 2020-02-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.