LOTUS Edge Valve System
FDA premarket approval P180029/S008 · decided 2019-10-30
Approval details
- PMA number
- P180029
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LOTUS Edge Valve System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-08-01
- Decision date
- 2019-10-30
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Approval for replacement of the current luer-activated valve component on the LOTUS Edge delivery system.
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