FDA.reportPublic FDA data

PMA P140031S129

Device
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Applicant
Edwards Lifesciences, LLC
PMA number
P140031
Supplement
S129
Product code
NPT
Decision date
2021-07-22
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Implementation of sterilization parametric release for the SAPIEN 3 Ultra Transcatheter Heart Valves (THVs) manufactured at the Edwards Irvine, CA and Changi, Singapore facilities.

Current openFDA PMA Record#

Device
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Applicant
Edwards Lifesciences, LLC
PMA number
P140031
Supplement
S129
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2021-07-22
Decision code
OK30
Date received
2021-06-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of sterilization parametric release for the SAPIEN 3 Ultra Transcatheter Heart Valves (THVs) manufactured at the Edwards Irvine, CA and Changi, Singapore facilities.