Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve
FDA premarket approval P150011/S030 · decided 2025-01-24
Approval details
- PMA number
- P150011
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Perceval Sutureless Heart Valve, Perceval PLUS Sutureless Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym S.r.l.
- Date received
- 2024-10-31
- Decision date
- 2025-01-24
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- approval for design changes related to the sutures and collar of the Perceval PLUS Sutureless Heart Valve, as well as manufacturing process changes. Manufacturing changes include the introduction of an automated laser cut process, introduction of a zero-pressure shaping process, and a change in the supplier of several suture threads.
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