HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES
FDA premarket approval P790007/S016 · decided 1999-09-29
Approval details
- PMA number
- P790007
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- HANCOCK MODIFIED ORIFICE, MODIFIED ORIFICE II AORTIC BIOPROSTHESES
- Generic name
- heart-valve, non-allograft tissue
- Applicant
- Medtronic Heart Valves
- Date received
- 1999-08-31
- Decision date
- 1999-09-29
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Ana, CA
- Statement
- Approval to relocate Medtronic's heart valve manufacturing facility from Irvine, CA, to 1851 East Deere Avenue, 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 |