LOTUS Edge Valve System
FDA premarket approval P180029/S004 · decided 2019-06-22
Approval details
- PMA number
- P180029
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LOTUS Edge Valve System
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-06-03
- Decision date
- 2019-06-22
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- NPT
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marborough, MA
- Statement
- Manufacturing and specification changes to the adaptive seal component of the 27-mm LOTUS Edge Valve.
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