FDA.reportPublic FDA data

PMA P140031S110

Device
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Applicant
Edwards Lifesciences, LLC
PMA number
P140031
Supplement
S110
Product code
NPT
Decision date
2020-03-11
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Eliminate the specification of "elastic" characteristic in pericardial tissue for tissue leaflets and the related visual inspection in the valve manufacturing process.

Current openFDA PMA Record#

Device
Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Applicant
Edwards Lifesciences, LLC
PMA number
P140031
Supplement
S110
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2020-03-11
Decision code
OK30
Date received
2020-02-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Eliminate the specification of "elastic" characteristic in pericardial tissue for tissue leaflets and the related visual inspection in the valve manufacturing process.