MAXUM System
FDA premarket approval P010023/S014 · decided 2020-10-28
Approval details
- PMA number
- P010023
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAXUM System
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Applicant
- Ototronix, LLC
- Date received
- 2020-09-28
- Decision date
- 2020-10-28
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Ethylene oxide (EO) sterilization process change for the implantable Magnet Canister Assembly.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PROCEM (K140644) | Ototronix, LLC | 2014-06-19 |
| NYSTAGRAM VIDEO NYSTAGMOGRAPHY SYSTEM (K130201) | Ototronix, LLC | 2013-04-26 |