PMA P140031S085
- Device
- SAPIEN 3 Ultra transcatheter heart valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S085
- Product code
- NPT
- Decision date
- 2019-08-16
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031S085B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- SAPIEN 3 Ultra transcatheter heart valve
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P140031
- Supplement
- S085
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-08-16
- Decision code
- APPR
- Date received
- 2019-04-01
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.