NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA premarket approval P890027/S038 · decided 1997-06-11
Approval details
- PMA number
- P890027
- Supplement
- S038
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1997-04-24
- Decision date
- 1997-06-11
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL TO IMPLEMENT A DESIGN CHANGE TO THE TWO-PIN SOCKET ON THE HEADSET MICROPHONE. THE TRANSMITTING COIL IS CONNECTED TO THE MICROPHONE VIA A CABLE WHICH IS PLUGGED INTO THIS TWO-PIN SOCKET. THIS CHANGE WOULD ALSO ENTAIL MAKING A SLIGHT MODIFICATION OT THE DESIGN OF THE SHELL OF THE HEADSET MICROPHONE IN ORDER TO ACCOMMODATE THE NEW DESIGN OF THE TWO-PIN SOCKET.
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