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.
| Device | MAXUM |
| Generic Name | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| Applicant | OTOTRONIX, LLC |
| Date Received | 2014-05-29 |
| Decision Date | 2015-05-04 |
| PMA | P010023 |
| Supplement | S011 |
| Product Code | MPV |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OTOTRONIX, LLC 26620 I-45 North houston, TX 77386 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010023 | | Original Filing |
| S014 |
2020-09-28 |
30-day Notice |
| S013 |
2015-09-15 |
135 Review Track For 30-day Notice |
| S012 |
2015-09-09 |
Normal 180 Day Track No User Fee |
| S011 |
2014-05-29 |
Normal 180 Day Track |
| S010 |
2013-06-13 |
Real-time Process |
| S009 |
2011-04-27 |
135 Review Track For 30-day Notice |
| S008 |
2010-12-21 |
30-day Notice |
| S007 |
2010-10-25 |
Normal 180 Day Track |
| S006 |
2010-09-15 |
Normal 180 Day Track No User Fee |
| S005 |
2010-07-27 |
Normal 180 Day Track No User Fee |
| S004 |
2010-07-07 |
Normal 180 Day Track |
| S003 |
2010-05-18 |
135 Review Track For 30-day Notice |
| S002 |
2009-08-19 |
Normal 180 Day Track No User Fee |
| S001 |
2001-11-21 |
Normal 180 Day Track |
NIH GUDID Devices