NECLEUS 24 COCHLEAR IMPLANT SYSTEM SOFTWARE
FDA premarket approval P970051/S007 · decided 1999-08-20
Approval details
- PMA number
- P970051
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NECLEUS 24 COCHLEAR IMPLANT SYSTEM SOFTWARE
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1999-08-13
- Decision date
- 1999-08-20
- Days to decision
- 7 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a software modification, the WinDPS Service Release 3.
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