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.
Installation of a laminar flow workbench to improve environmental controls and increase production capacity
| Device | Neuro Cochlear Implant System (“NCIS”) |
| Generic Name | Implant, Cochlear |
| Applicant | Oticon Medical |
| Date Received | 2021-08-23 |
| Decision Date | 2021-09-22 |
| PMA | P200021 |
| Supplement | S005 |
| Product Code | MCM |
| 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 | Oticon Medical 2720 Chemin Saint Bernard vallauris 06220 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200021 | Original Filing | |
| S014 | 2022-05-18 | 30-day Notice |
| S013 | ||
| S012 | 2022-04-29 | Normal 180 Day Track No User Fee |
| S011 | 2022-02-23 | 30-day Notice |
| S010 | 2021-12-15 | Normal 180 Day Track No User Fee |
| S009 | 2021-10-08 | 30-day Notice |
| S008 | ||
| S007 | 2021-09-27 | 30-day Notice |
| S006 | 2021-09-27 | 30-day Notice |
| S005 | 2021-08-23 | 30-day Notice |
| S004 | 2021-08-11 | 30-day Notice |
| S003 | 2021-08-11 | 30-day Notice |
| S002 | ||
| S001 | 2021-07-23 | Normal 180 Day Track No User Fee |