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.
Modifications to the acceptance criteria for the chemical composition of the feedthrough sandblasting material and to the leak test method for the magnet casing
| Device | Neuro Cochlear Implant System |
| Generic Name | Implant, Cochlear |
| Applicant | Oticon Medical |
| Date Received | 2021-08-11 |
| Decision Date | 2021-09-10 |
| PMA | P200021 |
| Supplement | S004 |
| 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 |