HiResolution Bionic Ear System/AIM System
FDA premarket approval P960058/S133 · decided 2019-04-12
Approval details
- PMA number
- P960058
- Supplement
- S133
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HiResolution Bionic Ear System/AIM System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2018-10-16
- Decision date
- 2019-04-12
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Approval for the AIM System components (with model numbers): AIM System (tablet) Cl-6126, AIM Power Adapter Cl-6132, AIM Sterile Inserts Cl-6120, AIM Tablet Power Cord (US) Cl-6127, AIM Programming Cable Cl-6125, AIM Software Cl-6056-001, AIM Insert Earphone Cl-6129, and AIM Rechargeable Battery Cl-6130.
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