SOUNDTEC DIRECT IPCA SYSTEM
FDA premarket approval P010023/S001 · decided 2002-09-04
Approval details
- PMA number
- P010023
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOUNDTEC DIRECT IPCA SYSTEM
- Generic name
- Implant, hearing, active, middle ear, partially implanted
- Applicant
- Ototronix, LLC
- Date received
- 2001-11-21
- Decision date
- 2002-09-04
- Days to decision
- 287 days
- Decision code
- APPR
- Product code
- MPV
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE SOUNDTEC DIRECT IPCA SYSTEM. THE INDICATIONS FOR USE HAS NOT BEEN CHANGED.
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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 |