NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P890027/S039 · decided 1997-12-28
Approval details
- PMA number
- P890027
- Supplement
- S039
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1997-07-01
- Decision date
- 1997-12-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for expansion ofthe indication for use of hte Nucleus 22 Channel Cochlear Implant to include children 18 months and older.
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