MAXUM
FDA premarket approval P010023/S011 · decided 2015-05-04
Approval details
- PMA number
- P010023
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MAXUM
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Applicant
- Ototronix, LLC
- Date received
- 2014-05-29
- Decision date
- 2015-05-04
- Days to decision
- 340 days
- Decision code
- APPR
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR CHANGING THE UNAIDED AIR CONDUCTION THRESHOLD UPPER LIMITS TO 60, 70, AND 85 DB HL AT FREQUENCIES OF 250, 500, AND 1000 HZ, RESPECTIVELY, AND TO 100 DB HL AT 2000, 3000, 4000, AND 6000 HZ AS PART OF THE PATIENT SELECTION CRITERIA.
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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 |