MAXUM
FDA premarket approval P010023/S010 · decided 2013-09-13
Approval details
- PMA number
- P010023
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MAXUM
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Applicant
- Ototronix, LLC
- Date received
- 2013-06-13
- Decision date
- 2013-09-13
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR USER INTERFACE SOFTWARE CHANGES AND PATIENT FITTING CHANGES TO THE OPTIMAX PROGRAMMER SOFTWARE.
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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 |