FDA.reportPublic FDA data

PMA P860057S197

Device
Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve
Applicant
Edwards Lifesciences, LLC
Product code
DYE
Decision date
2020-06-23
Generic name
replacement Heart-valve
Approval order statement
Approval for a labeling change for the Carpentier-Edwards PERIMOUNT® Magna Ease® Aortic Heart Valve, model 3300TFX, to update the Instructions for Use (IFU) reflecting data from the completed Post-Approval Study.

Current openFDA PMA Record#

Device
Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve
Applicant
Edwards Lifesciences, LLC
PMA number
P860057
Supplement
S197
Product code
DYE
Generic name
replacement Heart-valve
Decision date
2020-06-23
Decision code
APPR
Date received
2019-12-26
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a labeling change for the Carpentier-Edwards PERIMOUNT® Magna Ease® Aortic Heart Valve, model 3300TFX, to update the Instructions for Use (IFU) reflecting data from the completed Post-Approval Study.