PMA P140031S105
- Device
- SAPIEN 3 Ultra Transcatheter Heart Valve System (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S105
- Product code
- NPT
- Decision date
- 2020-01-16
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Use of the dry plant quality laboratory for routine environmental and manufacturing solution monitoring.
Current openFDA PMA Record#
- Device
- SAPIEN 3 Ultra Transcatheter Heart Valve System (THV)
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S105
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-01-16
- Decision code
- OK30
- Date received
- 2020-01-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of the dry plant quality laboratory for routine environmental and manufacturing solution monitoring.