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.
Approval for addition of technical notes to expand upon the information in the audiologists manual and to remind surgeons and audiologists of the importance of reporting significant injuries to cranial nerve vii via the medical device reporting system.
| Device | ESTEEM SYSTEM |
| Classification Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Generic Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Applicant | ENVOY MEDICAL CORPORATION |
| Date Received | 2013-05-01 |
| Decision Date | 2013-06-06 |
| PMA | P090018 |
| Supplement | S020 |
| Product Code | OAF |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ENVOY MEDICAL CORPORATION 4875 White Bear Parkway white Bear Lake, MN 55110 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090018 | Original Filing | |
| S041 | 2022-03-23 | Normal 180 Day Track No User Fee |
| S040 | ||
| S039 | 2019-09-05 | Normal 180 Day Track No User Fee |
| S038 | 2019-08-28 | 30-day Notice |
| S037 | 2018-05-02 | Real-time Process |
| S036 | 2017-05-10 | 30-day Notice |
| S035 | 2017-03-17 | 30-day Notice |
| S034 | 2017-03-13 | 135 Review Track For 30-day Notice |
| S033 | 2016-10-28 | Real-time Process |
| S032 | 2016-04-21 | Normal 180 Day Track No User Fee |
| S031 | 2016-02-04 | Normal 180 Day Track No User Fee |
| S030 | 2015-09-23 | Normal 180 Day Track No User Fee |
| S029 | 2015-03-23 | Real-time Process |
| S028 | 2014-12-31 | 30-day Notice |
| S027 | 2014-06-12 | Real-time Process |
| S026 | 2014-05-23 | Real-time Process |
| S025 | 2014-03-12 | 30-day Notice |
| S024 | 2013-08-08 | Real-time Process |
| S023 | 2013-08-01 | 30-day Notice |
| S022 | ||
| S021 | 2013-05-29 | 30-day Notice |
| S020 | 2013-05-01 | Special (immediate Track) |
| S019 | 2013-04-19 | Special (immediate Track) |
| S018 | 2012-08-29 | 30-day Notice |
| S017 | 2011-11-14 | 30-day Notice |
| S016 | 2011-11-02 | Normal 180 Day Track |
| S015 | ||
| S014 | 2011-10-24 | Real-time Process |
| S013 | 2011-08-26 | Real-time Process |
| S012 | 2011-08-16 | 30-day Notice |
| S011 | 2011-06-14 | 135 Review Track For 30-day Notice |
| S010 | 2011-05-20 | Normal 180 Day Track No User Fee |
| S009 | 2011-05-10 | Real-time Process |
| S008 | 2010-10-27 | 30-day Notice |
| S007 | 2010-08-18 | 30-day Notice |
| S006 | ||
| S005 | 2010-08-09 | 30-day Notice |
| S004 | 2010-07-27 | 135 Review Track For 30-day Notice |
| S003 | 2010-06-17 | Normal 180 Day Track No User Fee |
| S002 | 2010-06-17 | Normal 180 Day Track No User Fee |
| S001 | 2010-04-07 | Normal 180 Day Track |