Atlas FDA

Vibrant Soundbridge System

FDA premarket approval P990052/S026 · decided 2022-10-11

Approval details

PMA number
P990052
Supplement
S026
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
Vibrant Soundbridge System
Generic name
Implant, hearing, active, middle ear, partially implanted
Applicant
Med-El Elektromedizinische Gerate GmbH
Date received
2022-07-14
Decision date
2022-10-11
Days to decision
89 days
Decision code
APPR
Product code
MPV
Advisory committee
Ear, Nose, Throat
Expedited review
No
Location
Innsbruck
Statement
the SAMBA 2 VSB audio processor and the supporting SYMFIT 8.0.1 fitting software

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510(k) clearances by this applicant

RecordFirmDate
mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850) (K260718)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mGRIP Total Prosthesis (3.00 mm) (58689); mGRIP Total Prosthesis (3.25 mm) (58691); mGRIP Total Prosthesis (3.50 mm) (58693); mGRIP Total Prosthesis (3.75 mm) (58695); mGRIP Total Prosthesis (4.00 mm) (58697); mGRIP Total Prosthesis (4.25 mm) (58699); mGRIP Total Prosthesis (4.50 mm) (58701); mGRIP Total Prosthesis (4.75 mm) (58703); mGRIP Total Prosthesis (5.00 mm) (58705); mGRIP Total Prosthesis (5.50 mm) (58707); mGRIP Total Prosthesis (6.00 mm) (58709); mGRIP Total Prosthesis (6.50 (K260719)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735); (K260720)MED-EL Elektromedizinische Geräte GmbH2026-04-03
mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit (K241261)MED-EL Elektromedizinische Geräte GmbH2025-01-17
mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis (K241142)MED-EL Elektromedizinische Geräte GmbH2025-01-17
mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit (K241269)MED-EL Elektromedizinische Geräte GmbH2025-01-17