SOUNDTECH DIRECT AND MAXUM
FDA premarket approval P010023/S013 · decided 2016-03-22
Approval details
- PMA number
- P010023
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SOUNDTECH DIRECT AND MAXUM
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Applicant
- Ototronix, LLC
- Date received
- 2015-09-15
- Decision date
- 2016-03-22
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for a test fixture and inspection process change for the Magnet Canister Assembly (MCA).
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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 |