Perceval Sutureless Heart Valve
FDA premarket approval P150011/S013 · decided 2020-10-16
Approval details
- PMA number
- P150011
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Perceval Sutureless Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym S.r.l.
- Date received
- 2018-05-01
- Decision date
- 2020-10-16
- Days to decision
- 899 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- Approval for a new Perceval device model, the Perceval PLUS Sutureless Heart Valve, including a modification to the bovine pericardial tissue chemical treatment process and a reduction of the inflow ring height for the size XL valve.
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