PMA P900060S069

Device: Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S069
Product code: LWQ
Decision date: 2025-12-17
Classification: Cardiovascular
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: removal of an in-process inspection performed on valve sub-assemblies during the manufacturing process

Current openFDA PMA Record#

Device: Carbomedics Prosthetic Heart Valve; Carbomedics® Supra-annular Prosthetic Heart Valve; Carbo-Seal® Ascending Aortic Pros
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S069
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2025-12-17
Decision code: OK30
Date received: 2025-11-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of an in-process inspection performed on valve sub-assemblies during the manufacturing process