Product code MPV
- Device name
- Implant, Hearing, Active, Middle Ear, Partially Implanted
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- EN
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P990052S026 | Vibrant Soundbridge System | Med-El Elektromedizinische Gerate GmbH | 2022-10-11 |
| P010023S014 | MAXUM System | Ototronix, LLC | 2020-10-28 |
| P010023S012 | MAXUM SYSTEM | Ototronix, LLC | 2016-05-03 |
| P010023S013 | SOUNDTECH DIRECT AND MAXUM | Ototronix, LLC | 2016-03-22 |
| P010023S011 | MAXUM | Ototronix, LLC | 2015-05-04 |
| P990052S024 | VIBRANT SOUNDBRIDGE | Med-El Elektromedizinische Gerate GmbH | 2014-02-13 |
| P990052S023 | VIBRANT SOUNDBRIDGE SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2013-12-19 |
| P010023S010 | MAXUM | Ototronix, LLC | 2013-09-13 |
| P010023S007 | MAXUM SYSTEM | Ototronix, LLC | 2012-05-10 |
| P010023S009 | MAXUM SYSTEM | Ototronix, LLC | 2011-07-15 |
| P010023S004 | MAXUM SYSTEM | Ototronix, LLC | 2011-04-08 |
| P010023S008 | MAXUM SYSTEM | Ototronix, LLC | 2011-03-02 |
| P010023S006 | MAXUM SYSTEM | Ototronix, LLC | 2010-11-05 |
| P010023S003 | MAXUM SYSTEM | Ototronix, LLC | 2010-09-30 |
| P010023S005 | MAXUM SYSTEM | Ototronix, LLC | 2010-09-10 |
| P990052S022 | VIBRANT SOUNDBRIDGE SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2010-07-27 |
| P010023S002 | MAXUM SYSTEM | Ototronix, LLC | 2009-10-08 |
| P990052S020 | VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2009-01-09 |
| P990052S021 | VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2008-10-24 |
| P990052S019 | VIBRANT SOUNDBRIDGE EAR IMPLANT SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2008-03-25 |
| P990052S018 | VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2007-06-13 |
| P990052S016 | VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) | Med-El Elektromedizinische Gerate GmbH | 2007-03-30 |
| P990052S014 | VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE (IMEHD) | Med-El Elektromedizinische Gerate GmbH | 2006-12-14 |
| P990052S015 | VIBRANT SOUNDBRIDGE | Med-El Elektromedizinische Gerate GmbH | 2006-12-13 |
| P990052S013 | VIBRANT SOUNDBRIDGE | Med-El Elektromedizinische Gerate GmbH | 2006-11-02 |
| P990052S012 | VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2006-10-13 |
| P990052S011 | VIBRANT SOUNDBRIDGE IMPLANTABLE MIDDLE EAR HEARING DEVICE | Med-El Elektromedizinische Gerate GmbH | 2005-11-23 |
| P010023S001 | SOUNDTEC DIRECT IPCA SYSTEM | Ototronix, LLC | 2002-09-04 |
| P990052S008 | VIBRANT SOUNDBRIDGE SYSTEM | Med-El Elektromedizinische Gerate GmbH | 2002-07-02 |
| P990052S007 | VIBRANT SOUNDBRIDGE DIRECT DRIVE DEMONSTRATOR | Med-El Elektromedizinische Gerate GmbH | 2002-04-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09008737532925 | SAMBA 2 GO w/o manuals | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2022-11-16 |
| 09008737525033 | SYMFIT 8.0 Download | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737520472 | SAMBA 2 Remote (Android) | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737531065 | SYMFIT 8.0 Download | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737527969 | Remote Control | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737526030 | SAMBA 2 Remote (iOS) | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737525859 | SYMFIT 8.0 USB | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737525811 | SYMFIT 8.0 DVD | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| 09008737525071 | SAMBA 2 GO | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. | 2020-09-08 |
| M737M61021 | MAXUM | Ototronix, LLC | 2014-09-11 |
| M737M70171 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M70161 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M70151 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M70141 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M70131 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M70011 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M70001 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M61001 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M53001 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M52001 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M51001 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M420R1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M420L1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M410R1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M410L1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M31001 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M220R1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M220L1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M210R1 | MAXUM | Ototronix, LLC | 2014-09-03 |
| M737M210L1 | MAXUM | Ototronix, LLC | 2014-09-03 |