THE HANCOCK VALVE CONDUIT LOW POROSITY (MODEL 150)
FDA premarket approval P870078/S031 · decided 2016-04-28
Approval details
- PMA number
- P870078
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE HANCOCK VALVE CONDUIT LOW POROSITY (MODEL 150)
- Generic name
- replacement Heart-valve
- Applicant
- Medtronic, Inc.
- Date received
- 2016-01-29
- Decision date
- 2016-04-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- DYE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval for packaging and labeling changes for the Hancock Valved Conduit Modified Orifice (Model 105) and the Hancock Valved Conduit Low Porosity (Model 150).
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