PMA P130009S104
- Device
- Sapien XT Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S104
- Product code
- NPT
- Decision date
- 2019-11-24
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- to down classify gowning room 129 from ISO Class 7 to ISO Class 8 at the Irvine facility
Current openFDA PMA Record#
- Device
- Sapien XT Transcatheter Heart Valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S104
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-11-24
- Decision code
- OK30
- Date received
- 2019-11-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to down classify gowning room 129 from ISO Class 7 to ISO Class 8 at the Irvine facility