PMA P140031S096
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S096
- Product code
- NPT
- Decision date
- 2019-10-03
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Reduce the sampling plan from 100% to 4% LTPD for visual inspection of post-cleaned valve frames.
Current openFDA PMA Record#
- Device
- Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S096
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-10-03
- Decision code
- OK30
- Date received
- 2019-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the sampling plan from 100% to 4% LTPD for visual inspection of post-cleaned valve frames.