Chrysalis Intelligence · Sponsors · Oticon Medical AB

Oticon Medical AB

Askim, SE · 4 510(k) clearances · 14 PMAs

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Total clearances
4
2021-03-03 → 2024-07-10
Last 12 months
0
Product codes
3
Most recent
2024-07-10
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
LXB — — — 2 2021-12-16
PFO Active Implantable Bone Conduction Hearing System Class II Ear, Nose, Throat 1 2024-07-10
MAH — — — 1 2021-03-03
Class III

PMA approvals (14)

Total PMA records
14
Originals + supplements
Distinct product codes
1
First decision
2021-06-23
Most recent
2022-11-04
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2022-11-04 P200021-S013 Neuro Cochlear Implant System (NCIS) 135 Review Track For 30-Day Notice MCM Implant, Cochlear Unknown
2022-06-17 P200021-S014 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2022-05-27 P200021-S012 Neuro Cochlear Implant System (NCIS) Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2022-03-15 P200021-S011 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2022-01-14 P200021-S010 Neuro Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2021-11-08 P200021-S002 Neuro Cochlear Implant System Real-Time Process MCM Implant, Cochlear Unknown
2021-11-04 P200021-S009 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2021-10-26 P200021-S007 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2021-10-26 P200021-S006 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2021-09-22 P200021-S005 Neuro Cochlear Implant System (“NCIS”) 30-Day Notice MCM Implant, Cochlear Unknown
2021-09-10 P200021-S004 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2021-09-08 P200021-S003 Neuro Cochlear Implant System 30-Day Notice MCM Implant, Cochlear Unknown
2021-08-20 P200021-S001 Neuro Cochlear Implant System Normal 180 Day Track No User Fee MCM Implant, Cochlear Unknown
2021-06-23 P200021 Neuro Cochlear Implant System Original MCM Implant, Cochlear Unknown
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2024-07-10 K240614 Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS PFO Class II Ear, Nose, Throat
2021-12-16 K213733 Ponto 5 SuperPower LXB — —
2021-08-10 K211640 Ponto 5 Mini LXB — —
2021-03-03 K203807 Ponto Bone Anchored Hearing System, MONO Surgery Kit MAH — —
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence