PMA P130009S100
- Device
- Sapien XT Transcatheter Heart Valve and Accessories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S100
- Product code
- NPT
- Decision date
- 2019-09-17
- Classification
- Aortic Valve, Prosthesis, Percutaneously Delivered
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval for the introduction of 100% visual inspection of the Sapien XT introducer sheath.
Current openFDA PMA Record#
- Device
- Sapien XT Transcatheter Heart Valve and Accessories
- Applicant
- Edwards Lifesciences, LLC
- PMA number
- P130009
- Supplement
- S100
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2019-09-17
- Decision code
- APPR
- Date received
- 2019-08-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the introduction of 100% visual inspection of the Sapien XT introducer sheath.