FDA.reportPublic FDA data

PMA P860057S198

Device
Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE
Applicant
Edwards Lifesciences, LLC
PMA number
P860057
Supplement
S198
Product code
DYE
Decision date
2020-03-05
Generic name
replacement Heart-valve
Approval order statement
Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.

Current openFDA PMA Record#

Device
Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE
Applicant
Edwards Lifesciences, LLC
PMA number
P860057
Supplement
S198
Product code
DYE
Generic name
replacement Heart-valve
Decision date
2020-03-05
Decision code
OK30
Date received
2020-02-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves.