PMA P960058S020

Device: BTE(BEHIND-THE-EAR)T-MIC
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S020
Product code: MCM
Decision date: 2002-04-23
Classification: Implant, Cochlear
Generic name: Implant, cochlear
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.

Current openFDA PMA Record#

Device: BTE(BEHIND-THE-EAR)T-MIC
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S020
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-04-23
Decision code: APPR
Date received: 2002-04-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.