NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S031 · decided 1996-05-20
Approval details
- PMA number
- P890027
- Supplement
- S031
- 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
- 1996-04-24
- Decision date
- 1996-05-20
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR MODIFICATIONS TO THE EXTERNAL TRANSMITTER COIL OF THE NUCLEUS 22 CHANNEL COCHLEAR IMPLANT DEVICE. THE MODIFICATIONS CONSIST OF CONNECTING TWO DIODES IN PARALLEL WITH THE EXTERNAL TRANSMITTER COIL TO LIMIT ESD ENERGY BEING TRANSMITTED TO THE IMPLANT BY THE COIL. A CHANGE IN THE MANUFACTURING METHOD FOR THE COIL WINDINGS WILL ALSO REDUCE THE EFFECTIVE COIL DIAMETER BY APPROXIMATELY 0.1MM.
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