Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BTE(BEHIND-THE-EAR)T-MIC |
Generic Name | Implant, cochlear |
Applicant | ADVANCED BIONICS CORP. 12740 SAN FERNANDO RD. SYLMAR, CA 91342 |
PMA Number | P940022 |
Supplement Number | S020 |
Date Received | 04/12/2002 |
Decision Date | 04/23/2002 |
APCB Date
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10/18/2002 |
Product Code |
MCM |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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