PMA P180029
- Device
- LOTUS Edge Valve System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180029
- Supplement
- S030
- Product code
- NPT
- Decision date
- 2021-03-30
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Approval order statement
- Approval of revised protocols to truncate follow-up for the post-approval studies (PAS) protocol.
Current openFDA PMA Record#
- Device
- LOTUS Edge Valve System
- Applicant
- Boston Scientific Corporation
- PMA number
- P180029
- Supplement
- S030
- Product code
- NPT
- Generic name
- Aortic valve, prosthesis, percutaneously delivered
- Decision date
- 2021-03-30
- Decision code
- APPR
- Date received
- 2021-03-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of revised protocols to truncate follow-up for the post-approval studies (PAS) protocol.