NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
FDA premarket approval P890027/S028 · decided 1995-12-11
Approval details
- PMA number
- P890027
- Supplement
- S028
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1995-10-31
- Decision date
- 1995-12-11
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL TO MAKE CHANGES TO THE MINI 22 COCHLEAR IMPLANT INTEGRATED CIRCUIT (IC) TEST SOFTWARE (K15001) IN ORDER TO ADD SEVERAL TEST OF IMPORVED QUALITY ASSURANCE. ONE MODIFICATION YOU HAVE REQUESTED IS TO ADD A POWER SUPPLY LEAKAGE TEST TO AID IN ENSURING THAT THE BIPOLAR TANTALUM POWER SUPPLY CAPACITOR IS NOT ASSEMBLED IN THE REVERSE DIRECTION. THE SECOND MODIFICATION YOU HAVE REQUESTED IS TO IMPLEMENT AN AUTOMATIC EVALUATION OF THEDATA MESURED FROM THE INTEGRATED CIRCUIT PRIOR TO ITS FINAL AS
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