PMA P130009S037
- Device
- SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S037
- Product code
- NPT
- Decision date
- 2016-02-29
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for use in pediatric and adult patients with a dysfunctional, non-compliant Right Ventricular Outflow Tract (RVOT) conduit with a clinical indication for intervention and: 1) pulmonary regurgitation >= moderate and/or; and 2) mean RVOT gradient >= 35 mmHg.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S037B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S037
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2016-02-29
- Decision code
- APPR
- Date received
- 2015-07-01
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for use in pediatric and adult patients with a dysfunctional, non-compliant Right Ventricular Outflow Tract (RVOT) conduit with a clinical indication for intervention and: 1) pulmonary regurgitation >= moderate and/or; and 2) mean RVOT gradient >= 35 mmHg.