COCHLEAR'S MINI 22 COCHLEAR IMPLANT (MODEL CI22M)
FDA premarket approval P890027/S009 · decided 1993-04-05
Approval details
- PMA number
- P890027
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COCHLEAR'S MINI 22 COCHLEAR IMPLANT (MODEL CI22M)
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1992-01-13
- Decision date
- 1993-04-05
- Days to decision
- 448 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
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