HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
FDA premarket approval P790007/S007 · decided 1985-05-30
Approval details
- PMA number
- P790007
- Supplement
- S007
- Trade name
- HANCOCK MODIFIED ORIFICE BIOPROSTHESIS
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic Heart Valves
- Date received
- 1985-02-08
- Decision date
- 1985-05-30
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
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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 |