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 Implant System |
| Generic Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Applicant | Cochlear Americas13059 East Peakview Avenuecentennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-05-02 |
| Decision Date | 2022-06-16 |
| PMA | P130016 |
| Supplement | S049 |
| Product Code | PGQ |
| Advisory Committee | Ear Nose & Throat |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cochlear Americas 13059 East Peakview Avenue centennial, CO 80111 PMA NumberP130016 Supplement NumberS049 Date Received05/02/2022 Decision Date06/16/2022 Product Code PGQ Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement The Center For Devices And Radiological Health (CDRH) Of The Food And Drug Administration (FDA) Has Completed Its Review Of Your Premarket Approval Application (PMA) Supplement, Which Requested Approval Of The Revised Protocol For The Post-approval Study (PAS) Referenced Above (i.e., Change The Study Duration From 5-year Postactivation Follow-up To 3-year Postactiviation Follow-up). The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P130016 Dated March 20, 2014. Based Upon The Information Submitted, The PMA Supplement Is Approved. |
| 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 |