| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| Device | SOUNDTECH DIRECT AND MAXUM |
|---|---|
| Generic Name | Implant, hearing, active, middle ear, partially implanted |
| Applicant | OTOTRONIX, LLC 26620 I-45 NORTH HOUSTON, TX 77386 |
| PMA Number | P010023 |
| Supplement Number | S013 |
| Date Received | 09/15/2015 |
| Decision Date | 03/22/2016 |
| Product Code | MPV |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 135 Review Track For 30-Day Notice |
| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Expedited Review Granted? | No |
| Combination Product | No |
| Approval Order Statement Approval for a test fixture and inspection process change for the Magnet Canister Assembly (MCA). | |