NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P840024/S075 · decided 1998-04-01
Approval details
- PMA number
- P840024
- Supplement
- S075
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1998-03-18
- Decision date
- 1998-04-01
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- The 30-day Notice requested a change in the cleaning operations of the Cochlear Implant Components from the present use of Freon to the proposed use of a general purpose degreaser 4-850.
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