THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)
FDA premarket approval P790007/S047 · decided 2016-04-28
Approval details
- PMA number
- P790007
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE HANCOCK VALVED CONDUIT MODIFIED ORIFICE (MODEL 105)
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic Heart Valves
- Date received
- 2016-01-29
- Decision date
- 2016-04-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWR
- 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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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SIMPLICI-T ANNULOPLASTY SYSTEM (K052970) | Medtronic Heart Valves | 2006-01-11 |
| CG FUTURE ANNULOPLASTY BAND (K052860) | Medtronic Heart Valves | 2005-11-10 |
| DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE (K032810) | Medtronic Heart Valves | 2003-12-05 |