BTE(BEHIND-THE-EAR)T-MIC
FDA premarket approval P960058/S020 · decided 2002-04-23
Approval details
- PMA number
- P960058
- Supplement
- S020
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BTE(BEHIND-THE-EAR)T-MIC
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2002-04-12
- Decision date
- 2002-04-23
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR THE BTE T-MIC, AND IN-THE-EAR MICROPHONE ACCESSORY ITEM TO BE OFFERED FOR USE WITH THE BTE SOUND PROCESSOR, AND APPROVAL OF THE HIFOCUS I SURGICAL INSTRUCTION VIDEO, WHICH WILL BE DISTRIBUTED AS PART OF THE SURGEON'S KIT.
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