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 | Neuro Cochlear Implant System |
| Generic Name | Implant, Cochlear |
| Applicant | Oticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS014 Date Received05/18/2022 Decision Date06/17/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-18 |
| Decision Date | 2022-06-17 |
| PMA | P200021 |
| Supplement | S014 |
| 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 PMA NumberP200021 Supplement NumberS014 Date Received05/18/2022 Decision Date06/17/2022 Product Code MCM 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 (1) Improved Equipment And Manufacturing Workflow At The Electronic Assembly Supplier; And (2) Modification To The Tooling Used For Feedthrough Leak Testing |
| 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 |