NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S002 · decided 1998-07-22
Approval details
- PMA number
- P970051
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 1998-07-20
- Decision date
- 1998-07-22
- Days to decision
- 2 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- Approval for two minor design changes to the ESPrit (ear level) speech processor: 1) the addition of a 47uF capacitor; and 2) the lowering of the crystal Q with insertion of a low value resistor (R3-120). As stated in the submission and described in the telephone conference on July 22, 1998, these two changes have been tested and validated. With reference to item 1), this change would lower the total harmonic distoriton resulting in improved audio signal. In item 2) you would improve the oscilla
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