NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P890027/S043 · decided 1998-03-06
Approval details
- PMA number
- P890027
- Supplement
- S043
- Supplement type
- Special (Immediate 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
- 1998-02-09
- Decision date
- 1998-03-06
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for changes in the package insert labeling to 1) include the indication for children age 18 months to 17 years and 2) to modify the adverse effects section.
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