PMA P150011S028

Device: Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve
Applicant: Corcym S.r.l.
PMA number: P150011
Supplement: S028
Product code: LWR
Decision date: 2025-03-12
Classification: Cardiovascular
Generic name: heart-valve, non-allograft tissue
Approval order statement: approval for the following manufacturing site: Corcym S.r.l, Via Crescentino sn, 13040 Saluggia (VC) – ITALY, Operations to be performed: manufacturing, packaging, sterilization

Current openFDA PMA Record#

Device: Perceval Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve
Applicant: Corcym S.r.l.
PMA number: P150011
Supplement: S028
Product code: LWR
Generic name: heart-valve, non-allograft tissue
Decision date: 2025-03-12
Decision code: APPR
Date received: 2024-07-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the following manufacturing site: Corcym S.r.l, Via Crescentino sn, 13040 Saluggia (VC) – ITALY, Operations to be performed: manufacturing, packaging, sterilization