NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P840024/S088 · decided 2009-11-12
Approval details
- PMA number
- P840024
- Supplement
- S088
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NUCLEUS 22 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2009-10-13
- Decision date
- 2009-11-12
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR ADDITIONAL LABELING TO RECIPIENTS RECEIVING PRE-PROGRAMMED REPAIRED/REPLACED SOUND PROCESSORS.
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