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 | Nucleus 24 Auditory Brainstem Implant System |
| Generic Name | Implant, Auditory Brainstem |
| Applicant | Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP000015 Supplement NumberS048 Date Received09/07/2022 Decision Date12/06/2022 Product Code MHE Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-09-07 |
| Decision Date | 2022-12-06 |
| PMA | P000015 |
| Supplement | S048 |
| Product Code | MHE |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 PMA NumberP000015 Supplement NumberS048 Date Received09/07/2022 Decision Date12/06/2022 Product Code MHE Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For The Cochlear™ Nucleus® MRI Kit, An Accessory, Together With Associated Labeling Changes, To Allow Certain Nucleus Implant Recipients To Undergo MRI Scans At 1.5 T With The Implant Magnet In Place |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000015 | Original Filing | |
| S048 | 2022-09-07 | Real-time Process |
| S047 | 2022-04-26 | Normal 180 Day Track |
| S046 | 2021-06-21 | 135 Review Track For 30-day Notice |
| S045 | 2020-11-12 | 30-day Notice |
| S044 | ||
| S043 | 2020-07-15 | 30-day Notice |
| S042 | 2019-11-13 | 30-day Notice |
| S041 | ||
| S040 | ||
| S039 | 2019-07-31 | 30-day Notice |
| S038 | ||
| S037 | 2019-06-06 | 30-day Notice |
| S036 | ||
| S035 | 2019-01-30 | 30-day Notice |
| S034 | 2018-11-01 | Normal 180 Day Track |
| S033 | 2018-08-13 | 30-day Notice |
| S032 | 2018-04-13 | 30-day Notice |
| S031 | 2018-02-15 | 30-day Notice |
| S030 | 2018-02-02 | 30-day Notice |
| S029 | 2018-01-02 | 30-day Notice |
| S028 | 2018-01-02 | 30-day Notice |
| S027 | 2017-11-13 | Normal 180 Day Track |
| S026 | 2017-08-25 | 135 Review Track For 30-day Notice |
| S025 | 2017-08-07 | 30-day Notice |
| S024 | 2017-07-26 | 30-day Notice |
| S023 | 2017-06-21 | Real-time Process |
| S022 | 2017-06-07 | 30-day Notice |
| S021 | 2017-05-16 | 30-day Notice |
| S020 | 2017-04-10 | 30-day Notice |
| S019 | 2017-03-23 | 30-day Notice |
| S018 | 2016-11-23 | 30-day Notice |
| S017 | 2016-11-23 | 30-day Notice |
| S016 | 2016-10-12 | Normal 180 Day Track |
| S015 | 2016-09-22 | 30-day Notice |
| S014 | 2016-06-23 | 30-day Notice |
| S013 | ||
| S012 | 2015-12-18 | Normal 180 Day Track |
| S011 | 2009-10-13 | Special (immediate Track) |
| S010 | 2007-12-03 | Real-time Process |
| S009 | ||
| S008 | 2006-09-05 | 30-day Notice |
| S007 | ||
| S006 | 2005-03-09 | 30-day Notice |
| S005 | 2003-06-24 | Real-time Process |
| S004 | 2002-12-06 | Normal 180 Day Track |
| S003 | 2002-10-31 | Normal 180 Day Track |
| S002 | 2001-07-23 | Normal 180 Day Track |
| S001 | 2001-06-22 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 09321502020404 | P000015 | 012 |