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 NumberS047 Date Received02/01/2022 Decision Date03/03/2022 Product Code PGQ Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-03-03 |
| PMA | P130016 |
| Supplement | S047 |
| Product Code | PGQ |
| 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 NumberS047 Date Received02/01/2022 Decision Date03/03/2022 Product Code PGQ 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 the Introduction Of An Alternate Laser Welding System To The Current System, To Perform Hermitization Hole Welding In The Implant Assembly |
| 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 |