HiResolution Bionic Ear System - Universal Headpiece (UHP) 2.0
FDA premarket approval P960058/S125 · decided 2017-10-26
Approval details
- PMA number
- P960058
- Supplement
- S125
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System - Universal Headpiece (UHP) 2.0
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2017-09-29
- Decision date
- 2017-10-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Change the manufacturing process for the Universal Headpiece (UHP) which is part of the HiResolution Bionic Ear System.
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