Med El Corp

FDA Filings

This page includes the latest FDA filings for Med El Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Med El Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• PATRICIA BARFIELD MACY

FDA Registration(s)

• Registration Number: 1066702
• FEI Number: 3003370917
• Name: MED-EL CORP.
• Owner & Operator: MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH
• Contact Address: Fuerstenweg 77a ; Innsbruck AT-7 Tirol 6020 AT
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2645 Meridian Parkway, Suite 100 ; DURHAM, NC 27713 US

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P000025S122 MED-EL CORP.	MED-EL Cochlear Implant System	2021-09-03
PMA P000025S120 MED-EL CORP.	SONNET 2, SONNET 2 EAS, RONDO 3, MAESTRO 8, and MAESTRO 9	2021-06-25
PMA P000025S119 MED-EL CORP.	MED-EL Cochlear Implant System	2020-10-21
PMA P000025S118 MED-EL CORP.	MED-EL Cochlear Implant System	2020-09-04
PMA P000025S116 MED-EL CORP.	MED-EL Cochlear Implant System	2020-08-25
PMA P000025S113 MED-EL CORP.	COMBI 40+ Cochlear Implant System	2019-10-15
PMA P000025S112 MED-EL CORP.	Sonnet 2 (EAS) Audio Processor and Maestro 8.0 Software	2019-08-22
PMA P000025S110 MED-EL CORP.	Mi1250 SYNCHRONY 2 (PIN) Cochlear Implant	2019-06-04
PMA P000025S109 MED-EL CORP.	AudioKey 1.0 and AudioLink	2019-05-08
PMA P000025S108 MED-EL CORP.	FineTuner Echo	2019-05-08
PMA P000025S107 MED-EL CORP.	MED-EL Cochlear Implant System	2019-02-22
PMA P000025S103 MED-EL CORP.	Mi1210 SYNCHRONY ST Cochlear Implant	2019-01-22
PMA P000025S105 MED-EL CORP.	MED-EL Cochlear Implant System	2018-09-19
PMA P000025S102 MED-EL CORP.	MED-EL Cochlear Implant System	2018-08-10
PMA P000025S101 MED-EL CORP.	MED-EL Cochlear Implant System	2018-07-25
PMA P000025S097 MED-EL CORP.	Maestro System Software 7.0	2018-07-24
PMA P000025S099 MED-EL CORP.	RONDO 2 Audio Processor & WaterWear for RONDO 2	2018-05-15
PMA P000025S098 MED-EL CORP.	MED-EL Cochlear Implants	2018-04-20
PMA P000025S094 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2018-03-07
PMA P000025S096 MED-EL CORP.	Combi 40+ Cochlear Implant System	2017-07-12
PMA P000025S095 MED-EL CORP.	Combi 40+ Cochlear Implant System	2017-06-01
PMA P000025S093 MED-EL CORP.	COMBI 40+ Cochlear Implant System	2017-03-29
PMA P000025S089 MED-EL CORP.	SONNET/SONNET EAS AUDIO PROCESSORS AND MAESTRO 6.0	2017-02-16
PMA P000025S091 MED-EL CORP.	MI 1200 SYNCHRONY (PIN) COCHLEAR IMPLANT SYSTEM	2016-12-20
PMA P000025S092 MED-EL CORP.	MED-EL EAS EXTENDED COCHLEAR IMPLANT SYSTEM	2016-12-08
PMA P000025S090 MED-EL CORP.	Mi1200 Magnet Assembly	2016-11-22
PMA P000025S084 MED-EL CORP.	MED-EL COCHLEAR IMPLANT SYSTEM	2016-09-15
PMA P000025S088 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2016-07-08
PMA P000025S087 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2016-05-24
PMA P000025S086 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2016-05-11
PMA P000025S085 MED-EL CORP.	THE MED-EL C40 + COCHLEAR IMPLANT	2016-04-29
PMA P000025S083 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR IMPLANT SYSTEM)	2015-12-29
PMA P000025S082 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2015-12-03
PMA P000025S081 MED-EL CORP.	MED-EL COCHLEAR IMPLANT SYSTEM	2015-03-11
PMA P000025S079 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2015-01-20
PMA P000025S078 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2014-12-08
PMA P000025S080 MED-EL CORP.	MAESTRO COCHLEAR IMPLANT SYSTEM	2014-09-12
PMA P000025S077 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2014-06-24
PMA P000025S076 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2014-03-26
PMA P000025S074 MED-EL CORP.	COMBI 40+ COCHLEAR SYSTEM	2014-01-17
PMA P000025S072 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2014-01-10
PMA P000025S067 MED-EL CORP.	MED-EL COCHLEAR IMPLANT SYSTEM	2013-12-05
PMA P000025S070 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2013-09-25
PMA P000025S073 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2013-08-15
PMA P000025S071 MED-EL CORP.	MAESTRO COCHLEAR IMPLANT SYSTEM	2013-08-07
PMA P000025S063 MED-EL CORP.	MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)	2013-06-06
PMA P000025S069 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2013-05-29
PMA P000025S068 MED-EL CORP.	MED-EL COMBI 40+ COHLEAR IMPLANT SYSTEM	2013-05-16
PMA P000025S066 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM, ECA MODULES M7, M8, M9	2012-12-04
PMA P000025S058 MED-EL CORP.	MI1000 MED-EL CONCERT PIN COCHLEAR IMPLANT	2012-11-21
PMA P000025S064 MED-EL CORP.	MED-EL CONCERT IMPLANT	2012-11-01
PMA P000025S062 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2012-10-26
PMA P000025S065 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM (MAESTRO COCHLEAR SYSTEM)	2012-10-15
PMA P000025S057 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2012-04-30
PMA P000025S054 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2012-04-20
PMA P000025S061 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2012-03-28
PMA P000025S060 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2012-03-05
PMA P000025S059 MED-EL CORP.	MED-EL COCHLEAR IMPLANT SYSTEMS	2011-12-16
PMA P000025S056 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2011-09-23
PMA P000025S053 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2011-09-15
PMA P000025S055 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2011-09-02
PMA P000025S051 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2011-08-26
PMA P000025S052 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2011-07-22
PMA P000025S050 MED-EL CORP.	MED - EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2011-07-22
PMA P000025S048 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2010-10-01
PMA P000025S049 MED-EL CORP.	COMBI 40+ COCHLEAR SYSTEM (MAESTRO COCHLER IMPLANT SYSTEM)	2010-09-17
PMA P000025S047 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM STERILE BLISTERS WITH INTERNAL ANTIBLOCK	2010-09-03
PMA P000025S046 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2010-09-03
PMA P000025S045 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2010-07-26
PMA P000025S044 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2010-03-26
PMA P000025S043 MED-EL CORP.	SONATATI100 IMPLANT	2009-09-23
PMA P000025S041 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2009-09-03
PMA P000025S042 MED-EL CORP.	SONATATI100 IMPLANT	2009-06-12
PMA P000025S039 MED-EL CORP.	MED-EL COCHLEAR IMPLANT SYSTEMS	2009-04-30
PMA P000025S040 MED-EL CORP.	COMBI 40+ COCLEAR IMPLANT SYSTEM	2009-03-25
PMA P000025S035 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2008-12-19
PMA P000025S038 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2008-10-24
PMA P000025S037 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2008-10-09
PMA P000025S036 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2008-08-27
PMA P000025S017 MED-EL CORP.	COMBI 40+COCHLEAR IMPLANT SYSTEM	2008-07-10
PMA P000025S033 MED-EL CORP.	SONATA TI 100 COCHLEAR IMPLANT	2008-06-20
PMA P000025S034 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2008-06-13
PMA P000025S032 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM & MED EL C40+ COCHLEAR IMPLANT SYSTEM	2008-04-18
PMA P000025S031 MED-EL CORP.	MED EL C40+ COCHLEAR IMPLANT SYSTEM	2008-04-18
PMA P000025S029 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH OPUS 2 SPEECH PROCESSOR	2008-04-08
PMA P000025S026 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2008-03-14
PMA P000025S028 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2007-10-24
PMA P000025S027 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2007-09-25
PMA P000025S023 MED-EL CORP.	COMBO 40+ COCHLEAR IMPLANT SYSTEM	2007-09-24
PMA P000025S025 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2007-07-24
PMA P000025S024 MED-EL CORP.	COMBI 40+ COCHLEAR IMPLANT SYSTEM	2007-07-24
PMA P000025S021 MED-EL CORP.	SONATATI100 COCHLEAR IMPLANT	2007-06-22
PMA P000025S020 MED-EL CORP.	COMBI 40 + COCHLEAR IMPLANT SYSTEM AND PULSAR COCHLEAR IMPLANT SYSTEM	2006-05-31
PMA P000025S019 MED-EL CORP.	COMBI 40+ SYSTEM WITH C40+ OR PULSARCI100 COCHLEAR IMPLANTS	2005-07-25
PMA P000025S018 MED-EL CORP.	MED-EL COMBI 40+/PULSAR COCHLEAR IMPLANT SYSTEM	2005-02-28
PMA P000025S014 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSARCI100 COCHLEAR IMPLANT	2004-11-17
PMA P000025S012 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH MED-EL CI.STUDIO+ RELEASE VERSION 2.0 SOFTWARE	2004-05-14
PMA P000025S013 MED-EL CORP.	MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM	2004-02-25

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• MED-EL CORP.furstenweg 77ainnsbruck 6020 PMA NumberP000025 Supplement NumberS123 Date Received01/26/2022 Decision Date05/18/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• MED-EL CORP.furstenweg 77ainnsbruck 6020 PMA NumberP000025 Supplement NumberS124 Date Received02/17/2022 Decision Date05/17/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	3MTA7	MED-EL CORPORATION
CAGE Code	3MTA7	MED-EL CORPORATION
S.A.M. Registration	3MTA7 [141693585]	MED-EL CORPORATION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200530784	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	COCHELA STIMULATIONSDISPLAY	4 BOX
2020050616621	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	COCHELA STIMULATIONSDISPLAY	4 BOX
2020042437328	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	COCHELA STIMULATIONSDISPLAY	4 BOX
2020041865505	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	COCHELA STIMULATIONSDISPLAY	4 BOX
2020041867676	Stadersand,Federal Republic of Germany -> Charleston, South Carolina	COCHELA STIMULATIONS DISPLAY HS CODE:90230080	4 PKG