PMA P180029S028
- Device
- LOTUS Edge Valve System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180029
- Supplement
- S028
- Product code
- NPT
- Decision date
- 2020-11-06
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Modification to the acceptance criteria for visual inspection of the adaptive seal component of the LOTUS Edge valve.
Current openFDA PMA Record#
- Device
- LOTUS Edge Valve System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180029
- Supplement
- S028
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-11-06
- Decision code
- OK30
- Date received
- 2020-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the acceptance criteria for visual inspection of the adaptive seal component of the LOTUS Edge valve.