MINI SPEECH PROCESSOR
FDA premarket approval P890027/S018 · decided 1994-04-28
Approval details
- PMA number
- P890027
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MINI SPEECH PROCESSOR
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1993-06-03
- Decision date
- 1994-04-28
- Days to decision
- 329 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
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