NUCLEUS 22 CHANNEL COCHLEAR
FDA premarket approval P840024/S046 · decided 1995-08-21
Approval details
- PMA number
- P840024
- Supplement
- S046
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1992-08-28
- Decision date
- 1995-08-21
- Days to decision
- 1088 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR NUCLEUS 22-CHANNEL COCHLEAR IMPLANT FOR USE IN AN EXPANDED ADULT POPULATION.
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