HARMONY HIRESOLUTION BIONIC EAR SYSTEM
FDA premarket approval P960058/S061 · decided 2008-04-21
Approval details
- PMA number
- P960058
- Supplement
- S061
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HARMONY HIRESOLUTION BIONIC EAR SYSTEM
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2008-03-24
- Decision date
- 2008-04-21
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- APPROVAL FOR AN UPDATED CHANGE TO THE INSTRUCTIONS FOR USE (IFU) FOR THE ICONNECT, AS ACCESSORY TO THE ADVANCED BIONICS BEHIND-THE-EAR SPEECH PROCESSORS, AS FOLLOWS: FROM: ?THE AURIA ICONNECT CAN ONLY USE A STANDARD SIZE 10 BATTERY. DO NOT USE ANY OTHER BATTERY.? TO: ?ONLY ZENIPOWER SIZE 10A BATTERIES FROM ADVANCED BIONICS ARE CERTIFIED FOR USE WITH THE ICONNECT. PLEASE CONTACT ADVANCED BIONICS OF ITS AUTHORIZED DISTRIBUTORS TO PURCHASE THESE BATTERIES. OTHER BATTERIES MAY NOT PROVIDE SUFFICIENT
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