ESPRIT22 SPEECH PROCESSOR
FDA premarket approval P890027/S048 · decided 1999-12-23
Approval details
- PMA number
- P890027
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESPRIT22 SPEECH PROCESSOR
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1999-10-20
- Decision date
- 1999-12-23
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for the ESPrit 22 Speech Processor.
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