PMA P900060S068

Device: CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S068
Product code: LWQ
Decision date: 2025-05-15
Classification: Cardiovascular
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: approval for the introduction of a new supplier of PET fabric, sewing changes impacting the cuff component of CPHV devices, and the removal of the Carbofilm coating from PET fabric

Current openFDA PMA Record#

Device: CARBOMEDICS Prosthetic Heart Valve; CARBOMEDICS Supra-Annular Prosthetic Heart Valve (Top Hat); ORBIS Prosthetic Heart V
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S068
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2025-05-15
Decision code: APPR
Date received: 2025-02-14
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the introduction of a new supplier of PET fabric, sewing changes impacting the cuff component of CPHV devices, and the removal of the Carbofilm coating from PET fabric