MAXUM SYSTEM
FDA premarket approval P010023/S003 · decided 2010-09-30
Approval details
- PMA number
- P010023
- Supplement
- S003
- Supplement type
- 135 Review Track For 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
- 2010-05-18
- Decision date
- 2010-09-30
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR A CHANGE IN THE MAGNET CANISTER MANUFACTURING PROCESS/INSPECTION, AND THE RE-QUALIFICATION OF THE MAGNETIZATION VENDOR AT THE VENDOR¿S NEW FACILITY LOCATION.
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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 |