PMA P900060

Device: CARBOMEDICS PROSTHETIC HEART VALVE, CARBOMEDICS® SUPRA-ANNULAR PROSTHETIC HEART VALVE, OPTIFORM® PROSTHETIC MITRAL HEART
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S064
Product code: LWQ
Decision date: 2026-07-28
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: implementing equipment to automatically conduct dimensional and visual inspections during the manufacturing process

Current openFDA PMA Record#

Device: CARBOMEDICS PROSTHETIC HEART VALVE, CARBOMEDICS® SUPRA-ANNULAR PROSTHETIC HEART VALVE, OPTIFORM® PROSTHETIC MITRAL HEART
Applicant: Corcym S.r.l.
PMA number: P900060
Supplement: S070
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2026-07-28
Decision code: OK30
Date received: 2026-06-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: implementing equipment to automatically conduct dimensional and visual inspections during the manufacturing process