Perceval Sutureless Heart Valve
FDA premarket approval P150011/S011 · decided 2018-02-08
Approval details
- PMA number
- P150011
- Supplement
- S011
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Perceval Sutureless Heart Valve
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym S.r.l.
- Date received
- 2017-07-24
- Decision date
- 2018-02-08
- Days to decision
- 199 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- Approval for a new manufacturing assembly tool and changes to the tissue sewing process.
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