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PMA P860057S199

Device
Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward
Applicant
Edwards Lifesciences, LLC
PMA number
P860057
Supplement
S199
Product code
DYE
Decision date
2020-03-11
Generic name
replacement Heart-valve
Approval order statement
Eliminate the specification of "elastic" characteristic in pericardial tissue for tissue leaflets and the related visual inspection in the valve manufacturing process.

Current openFDA PMA Record#

Device
Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward
Applicant
Edwards Lifesciences, LLC
PMA number
P860057
Supplement
S199
Product code
DYE
Generic name
replacement Heart-valve
Decision date
2020-03-11
Decision code
OK30
Date received
2020-02-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Eliminate the specification of "elastic" characteristic in pericardial tissue for tissue leaflets and the related visual inspection in the valve manufacturing process.