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EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
EDWARDS LIFESCIENCES, LLC.
Trade Name
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
Generic Name
heart-valve, non-allograft tissue
Decision Date
6/29/2017
Days to Decision
549 days
Decision Code
APPR
FDA Decision
Approval

EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
EDWARDS LIFESCIENCES, LLC.
Trade Name
EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500)
Generic Name
heart-valve, non-allograft tissue
Decision Date
6/29/2017
Days to Decision
549 days
Decision Code
APPR
FDA Decision
Approval