PERCEVAL HEART VALVE
FDA premarket approval P150011/S006 · decided 2017-01-10
Approval details
- PMA number
- P150011
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERCEVAL HEART VALVE
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Corcym S.r.l.
- Date received
- 2016-12-15
- Decision date
- 2017-01-10
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Saluggia
- Statement
- Approval for labeling changes.
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