- Device
- LOTUS Edge Valve System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180029
- Supplement
- S027
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2020-10-07
- Decision code
- OK30
- Date received
- 2020-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to acceptance criteria for visual inspection of the Multi-Lumen Extrusion (MLE) component of the LOTUS Edge delivery system.