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EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
EDWARDS LIFESCIENCES LLC.
Trade Name
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Generic Name
Aortic valve, prosthesis, percutaneously delivered
Decision Date
10/19/2012
Days to Decision
536 days
Decision Code
APWD
FDA Decision
Withdrawal after approval

EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
EDWARDS LIFESCIENCES LLC.
Trade Name
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
Generic Name
Aortic valve, prosthesis, percutaneously delivered
Decision Date
10/19/2012
Days to Decision
536 days
Decision Code
APWD
FDA Decision
Withdrawal after approval