SONATA TI 100 COCHLEAR IMPLANT
FDA premarket approval P000025/S033 · decided 2008-06-20
Approval details
- PMA number
- P000025
- Supplement
- S033
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SONATA TI 100 COCHLEAR IMPLANT
- Generic name
- Implant, cochlear
- Applicant
- Med-El Corp.
- Date received
- 2008-04-28
- Decision date
- 2008-06-20
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Innsbruck
- Statement
- APPROVAL FOR THE USE OF AN ALTERNATIVE HYBRID COMPONENT IN THE MANUFACTURE OF THE SONATATI100 COCHLEAR IMPLANT CALLED THE ¿SONATA HYBRID 2¿. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SONATATI100 COCHLEAR IMPLANT AND IS INDICATED FOR THE FOLLOWING PATIENT POPULATIONS: ADULTS EIGHTEEN (18) YEARS OF AGE OR OLDER WHO HAVE BILATERAL, SENSORINEURAL HEARING IMPAIRMENT AND OBTAIN LIMITED BENEFIT FROM APPROPRIATELY FITTED BINAURAL HEARING AIDS. THESE INDIVIDUALS TYPICALLY DEMONSTRATE
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