Hancock Modified Orifice Valved Conduit
FDA premarket approval P790007/S064 · decided 2020-12-16
Approval details
- PMA number
- P790007
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Hancock Modified Orifice Valved Conduit
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic Heart Valves
- Date received
- 2020-11-19
- Decision date
- 2020-12-16
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Change in storage temperature requirements for the tissue fixation solution.
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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 |