PMA P860057S191

Device: Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S191
Product code: DYE
Decision date: 2019-09-24
Classification: Replacement Heart-valve
Generic name: replacement Heart-valve
Approval order statement: Expansion of the Heart Valve Center Chemical Mixing Suite and increased manning of the Chemical Mixing Suite at the Irvine facility.

Current openFDA PMA Record#

Device: Carpentier-Edwards PERIMOUNT/PERIMOUNT RSR/Magna Pericardial Aortic Bioprosthesis; Carpentir-Edwards PERIMOUNT Theon/PER
Applicant: Edwards Lifesciences, LLC
PMA number: P860057
Supplement: S191
Product code: DYE
Generic name: replacement Heart-valve
Decision date: 2019-09-24
Decision code: OK30
Date received: 2019-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Expansion of the Heart Valve Center Chemical Mixing Suite and increased manning of the Chemical Mixing Suite at the Irvine facility.