NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S029 · decided 1996-03-26
Approval details
- PMA number
- P890027
- Supplement
- S029
- 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
- 1995-11-24
- Decision date
- 1996-03-26
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE FOLLOWING CHANGES TO THE SPECTRA 22 SPEECH PROCESSOR: 1)THE PRINTED CIRCUIT BOARD WILL BE REDESIGNED FROM A MULTI-LAYER BOARD CONFIGURATION TO A SINGLE-LAYER BOARD CONFIGURATION. 2)AN AUDIO MIXING FUNCTION, CALLED THE AUTOSWITCHING AUDIO CIRCUIT, WILL BE INCLUDED. 3)THE CLOCK OSCILLATOR FREQUENCY WILL BE CHANGED FROM A NOMINAL 5 MHZ TO 5.011 MHZ. 4) COMPONENTS WILL BE ADDED TO GIVE FURTHER PROTECTION FROM ELECTROSTATIC DISCHARGE (ESD). 5)THE EAR-LEVEL MICROPHONE POWER SUPPLY WIL
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.