CI24R(ST) COCHLEAR IMPLANT
FDA premarket approval P970051/S010 · decided 2000-08-21
Approval details
- PMA number
- P970051
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CI24R(ST) COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2000-02-23
- Decision date
- 2000-08-21
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR A DESIGN MODIFICATION INCLUDING THE STRAIGHT ELECTRODE OF THE CI 24 M WITH THE 24 K DOWNSIZED STIMULATOR RECEIVER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CI 24R(ST), AND IS INDICATED FOR CHILDREN AGE 18 MONTHS THROUGH 17 YEARS OF AGE WHO HAVE BILATERAL PROFOUND SENSORINEURAL DEAFNESS AND DEMONSTRATE LITTLE OR NO BENEFIT FROM APPROPRIATE BINAURAL HEARING AIDS, AND FOR ADULTS, AGE 18 YEARS AND OLDER WHO HAVE BILATERAL MODERATE TO PROFOUND SENSORINEURAL HEARING
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