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® Hybrid™ L24 Cochlear Implant System |
| Generic Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Applicant | Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS050 Date Received07/11/2022 Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-11 |
| PMA | P130016 |
| Supplement | S050 |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 PMA NumberP130016 Supplement NumberS050 Date Received07/11/2022 Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement Additional Laser Welding System For The Top Shell To Shield Welding Process. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130016 | Original Filing | |
| S051 | 2022-09-07 | Real-time Process |
| S050 | 2022-07-11 | 30-day Notice |
| S049 | 2022-05-02 | Normal 180 Day Track No User Fee |
| S048 | ||
| S047 | 2022-02-01 | 30-day Notice |
| S046 | ||
| S045 | 2020-11-12 | 30-day Notice |
| S044 | ||
| S043 | 2020-01-14 | Special (immediate Track) |
| S042 | ||
| S041 | ||
| S040 | ||
| S039 | ||
| S038 | 2019-06-07 | Normal 180 Day Track No User Fee |
| S037 | 2019-01-30 | 30-day Notice |
| S036 | 2018-11-01 | Normal 180 Day Track |
| S035 | 2018-08-13 | 30-day Notice |
| S034 | 2018-02-15 | 30-day Notice |
| S033 | 2018-01-02 | 30-day Notice |
| S032 | 2017-11-13 | Normal 180 Day Track |
| S031 | 2017-07-17 | 30-day Notice |
| S030 | 2017-06-21 | Real-time Process |
| S029 | 2017-06-07 | 30-day Notice |
| S028 | 2017-05-23 | Normal 180 Day Track |
| S027 | 2017-05-16 | 30-day Notice |
| S026 | 2017-04-24 | 30-day Notice |
| S025 | 2017-04-10 | 30-day Notice |
| S024 | 2017-03-23 | 30-day Notice |
| S023 | 2017-02-27 | 30-day Notice |
| S022 | 2016-10-12 | Normal 180 Day Track |
| S021 | 2016-10-06 | Normal 180 Day Track No User Fee |
| S020 | 2016-07-25 | 30-day Notice |
| S019 | 2016-06-15 | 135 Review Track For 30-day Notice |
| S018 | 2016-02-24 | 30-day Notice |
| S017 | 2016-02-24 | Normal 180 Day Track |
| S016 | 2016-02-08 | Normal 180 Day Track |
| S015 | 2016-01-06 | 30-day Notice |
| S014 | 2016-01-05 | 30-day Notice |
| S013 | 2015-12-04 | 30-day Notice |
| S012 | 2015-11-23 | Normal 180 Day Track |
| S011 | 2015-02-13 | 30-day Notice |
| S010 | 2014-12-24 | 30-day Notice |
| S009 | 2014-09-24 | Normal 180 Day Track No User Fee |
| S008 | 2014-07-23 | 30-day Notice |
| S007 | 2014-06-09 | Real-time Process |
| S006 | 2014-05-16 | 30-day Notice |
| S005 | 2014-05-01 | Normal 180 Day Track |
| S004 | 2014-04-18 | Normal 180 Day Track No User Fee |
| S003 | 2014-04-18 | Normal 180 Day Track No User Fee |
| S002 | 2014-04-02 | Real-time Process |
| S001 | 2014-03-28 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 09321502012089 | P130016 | 000 |
| 09321502023979 | P130016 | 000 |
| 09321502023962 | P130016 | 000 |
| 09321502023313 | P130016 | 000 |
| 09321502023306 | P130016 | 000 |
| 09321502025034 | P130016 | 000 |
| 09321502024082 | P130016 | 000 |
| 09321502024068 | P130016 | 000 |
| 09321502024051 | P130016 | 000 |
| 09321502024044 | P130016 | 000 |
| 09321502024037 | P130016 | 000 |
| 09321502024020 | P130016 | 000 |
| 09321502024013 | P130016 | 000 |
| 09321502024006 | P130016 | 000 |
| 09321502023337 | P130016 | 000 |
| 09321502023320 | P130016 | 000 |
| 09321502023986 | P130016 | 000 |
| 09321502023993 | P130016 | 000 |
| 09321502027441 | P130016 | 000 |
| 09321502025065 | P130016 | 000 |
| 09321502025041 | P130016 | 000 |
| 09321502025027 | P130016 | 000 |
| 09321502025010 | P130016 | 000 |
| 09321502025003 | P130016 | 000 |
| 09321502024990 | P130016 | 000 |
| 09321502024983 | P130016 | 000 |
| 09321502024976 | P130016 | 000 |
| 09321502024969 | P130016 | 000 |
| 09321502024952 | P130016 | 000 |
| 09321502024945 | P130016 | 000 |
| 09321502024938 | P130016 | 000 |
| 09321502024099 | P130016 | 000 |
| 09321502024075 | P130016 | 000 |
| 09321502022859 | P130016 | 000 |