COCHLEAR NUCLEUS 5 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S068 · decided 2011-04-07
Approval details
- PMA number
- P970051
- Supplement
- S068
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- COCHLEAR NUCLEUS 5 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2011-03-10
- Decision date
- 2011-04-07
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR ADDITIONAL LABELING FOR THE CI500 SERIES COCHLEAR IMPLANT.
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