COCHLEAR IMPLANT SYSTEM
FDA premarket approval P970051/S050 · decided 2010-02-02
Approval details
- PMA number
- P970051
- Supplement
- S050
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COCHLEAR IMPLANT SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Cochlear Americas
- Date received
- 2009-05-20
- Decision date
- 2010-02-02
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Lone Tree, CO
- Statement
- APPROVAL FOR THE MATERIAL USED IN THE GREY TRANSMITTING COIL FOR THE FREEDOM SOUND PROCESSOR FROM SABIC ABS CYCOLAC GPM5500 TO SABIC MEDICAL GRADE ABS CYCOLAC HMG94MD.
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