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VIBRANT SOUNDBRIDGE SYSTEM

FDA premarket approval P990052/S004 · decided 2001-07-24

Approval details

PMA number
P990052
Supplement
S004
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
2001-06-20
Decision date
2001-07-24
Days to decision
34 days
Decision code
APPR
Product code
MPV
Advisory committee
Ear, Nose, Throat
Expedited review
No
Location
Innsbruck
Statement
APPROVAL FOR MODIFICATION TO THE MOUNTING OF THE ELECTRONIC MODULE ASSEMBLY, THE MICROPHONE AND THE PROGRAMMING SOCKET; CHANGE IN THE PHYSICAL SHAPE OF THE MAGNET FROM A NOTCHED-SHAPE TO A FULL ROUND SHAPE; CHANGE IN THE MATERIAL OF THE TIP COVER OF THE AUDIO PROCESSOR (AP) TO ACRYLONITRILE-BUTADIENE-STYRENE COPOLYMER (ABS) AND ADDITION OF THREE DIFFERENT COLORS (LIGHT BROWN, BROWN AND GRAY) TO BETTER MATCH THE HAIR COLORS OF THE FINAL USERS; AND PICTORIAL AND TEXT CHANGES TO REFLECT THE NEW SHA

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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