Approval for an mr indication at 1. 5 tesla under specific scanning conditions with the magnet surgically removed prior to the mr scan, for the hybrid l24 implant system.
| Device | NUCLEUS HYBRID L24 IMPLANT SYSTEM |
| Classification Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Generic Name | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification |
| Applicant | Cochlear Americas |
| Date Received | 2014-04-02 |
| Decision Date | 2014-07-01 |
| PMA | P130016 |
| Supplement | S002 |
| Product Code | PGQ |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices