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 | Esteem® Totally Implantable Hearing System |
| Generic Name | Implant, Hearing, Active, Middle Ear, Totally Implanted |
| Applicant | ENVOY MEDICAL CORPORATION4875 White Bear Parkwaywhite Bear Lake, MN 55110 PMA NumberP090018 Supplement NumberS041 Date Received03/23/2022 Decision Date08/24/2022 Product Code OAF Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No |
| Date Received | 2022-03-23 |
| Decision Date | 2022-08-24 |
| PMA | P090018 |
| Supplement | S041 |
| Product Code | OAF |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ENVOY MEDICAL CORPORATION 4875 White Bear Parkway white Bear Lake, MN 55110 PMA NumberP090018 Supplement NumberS041 Date Received03/23/2022 Decision Date08/24/2022 Product Code OAF Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of Final Labeling Changes For The Post-approval Study (PAS) Referenced Above. The Updates To The Final PAS Labeling Have Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P090018. |
| 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 |