NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S030 · decided 1996-04-04
Approval details
- PMA number
- P890027
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1996-02-23
- Decision date
- 1996-04-04
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- MODIFICATIONS TO THE AUDIO INPUT SELECTOR (AIS), AN OPTIONAL ACCESSORY FOR THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF REPLACING THE AUGAT, TYPE ASE/F/FO SERIES SWITCHES WITH AUGAT, YPE MMS SERIES SWITCHES AND REMOUNTING RESISTORS R1 AND R2 TO THE SURFACE OF THE PCB
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