HiResolution Bionic Ear System
FDA premarket approval P960058/S136 · decided 2019-03-08
Approval details
- PMA number
- P960058
- Supplement
- S136
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HiResolution Bionic Ear System
- Generic name
- Implant, cochlear
- Applicant
- Advanced Bionics
- Date received
- 2019-01-29
- Decision date
- 2019-03-08
- Days to decision
- 38 days
- Decision code
- OK30
- Product code
- MCM
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Valencia, CA
- Statement
- Modification of the software controlling the sterilization chamber at Sterigenics, Salt Lake City, Utah.
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