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 (NCIS) |
| Generic Name | Implant, Cochlear |
| Applicant | Oticon Medical2720 Chemin Saint Bernardvallauris 06220 PMA NumberP200021 Supplement NumberS012 Date Received04/29/2022 Decision Date05/27/2022 Product Code MCM Advisory Committee Ear Nose & Throat Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-04-29 |
| Decision Date | 2022-05-27 |
| PMA | P200021 |
| Supplement | S012 |
| Product Code | MCM |
| 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 | Oticon Medical 2720 Chemin Saint Bernard vallauris 06220 PMA NumberP200021 Supplement NumberS012 Date Received04/29/2022 Decision Date05/27/2022 Product Code MCM 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 Changes (e.g., Additional Minor Changes To The Protocol To Align With US Sites’ Routine Practice Reported To Oticon Medical In The Course Of Study Site Recruitment) Of The Protocol For The Post-approval Study (PAS) Referenced Above. The PAS Protocol Has Been Submitted To Comply With The Conditions Of Approval Outlined In Our Approval Order For P200021. Based Upon The Information Submitted, The PMA Supplement Is Approved. |
| 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 |