NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (2-METER INTRA-OPERATIIVE CABLE
FDA premarket approval P970051/S005 · decided 1999-05-12
Approval details
- PMA number
- P970051
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (2-METER INTRA-OPERATIIVE CABLE
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1999-03-26
- Decision date
- 1999-05-12
- Days to decision
- 47 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for a longer two meter cable for use with the H58 handset in the Nucleus 24 Cochlear Implant System.
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