Approval for a manufacturing site located at ototronix llc, 5000 township parkway, st. Paul, minnesota to perform manufacturing and distribution.
| Device | MAXUM SYSTEM |
| Generic Name | Implant, Hearing, Active, Middle Ear, Partially Implanted |
| Applicant | OTOTRONIX, LLC |
| Date Received | 2015-09-09 |
| Decision Date | 2016-05-03 |
| PMA | P010023 |
| Supplement | S012 |
| Product Code | MPV |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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