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LOTUS Edge Valve System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Boston Scientific Corporation
Trade Name
LOTUS Edge Valve System
Generic Name
Aortic valve, prosthesis, percutaneously delivered
Decision Date
4/23/2019
Days to Decision
252 days
Decision Code
APWD
FDA Decision
Withdrawal after approval

LOTUS Edge Valve System

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Boston Scientific Corporation
Trade Name
LOTUS Edge Valve System
Generic Name
Aortic valve, prosthesis, percutaneously delivered
Decision Date
4/23/2019
Days to Decision
252 days
Decision Code
APWD
FDA Decision
Withdrawal after approval