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. |
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Device | MAXUM SYSTEM |
Generic Name | Implant, hearing, active, middle ear, partially implanted |
Applicant | OTOTRONIX, LLC 26620 I-45 NORTH HOUSTON, TX 77386 |
PMA Number | P010023 |
Supplement Number | S004 |
Date Received | 07/07/2010 |
Decision Date | 04/08/2011 |
Product Code |
MPV |
Advisory Committee |
Ear Nose & Throat |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CHANGE TO A DIGITAL PROCESSOR IN THE EXTERNAL INTEGRATED PROCESSOR AND COIL (IPC). THE MAXUM DIGITAL IPC REPLACES THE ANALOG PROCESSOR WITH A STANDARD COMMERCIAL DIGITAL PROCESSOR INTENDED FOR HEARING AID USE. |
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