Advanced Bionics

FDA Filings

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

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMA P960058S154 ADVANCED BIONICS	HiResolution Bionic Ear System	2022-01-14
PMA P960058S153 ADVANCED BIONICS	HiResolution Bionic Ear System	2021-04-29
PMA P960058S152 ADVANCED BIONICS	HiResolution Bionic Ear System	2021-04-23
PMA P960058S151 ADVANCED BIONICS	HiResolution Bionic Ear System	2020-12-22
PMA P960058S150 ADVANCED BIONICS	HiResolution Bionic Ear System	2020-07-22
PMA P960058S148 ADVANCED BIONICS	HiResolution Bionic Ear System	2020-05-28
PMA P960058S147 ADVANCED BIONICS	HiResolution Bionic Ear System	2020-01-17
PMA P960058S146 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-12-17
PMA P960058S143 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-10-25
PMA P960058S142 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-08-27
PMA P960058S141 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-08-23
PMA P960058S139 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-07-18
PMA P960058S140 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-07-03
PMA P960058S138 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-03-22
PMA P960058S132 ADVANCED BIONICS	Chorus Sound Processor and SoundWave Professional Suite 3.2/HiResolution Bionic Ear System	2019-03-12
PMA P960058S137 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-03-08
PMA P960058S136 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-03-08
PMA P960058S135 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-01-11
PMA P960058S134 ADVANCED BIONICS	HiResolution Bionic Ear System	2019-01-09
PMA P960058S129 ADVANCED BIONICS	HiRes Ultra 3D Cochlear Implant	2018-08-28
PMA P960058S130 ADVANCED BIONICS	HiResolution Bionic Ear System	2018-08-13
PMA P960058S128 ADVANCED BIONICS	HiResolution Bionic Ear System	2018-03-14
PMA P960058S126 ADVANCED BIONICS	HiResolution Bionic Ear System	2017-11-21
PMA P960058S122 ADVANCED BIONICS	HiResolution Bionic Ear System	2017-11-14
PMA P960058S121 ADVANCED BIONICS	HiFocus SlimJ Electrode	2017-11-14
PMA P960058S125 ADVANCED BIONICS	HiResolution Bionic Ear System - Universal Headpiece (UHP) 2.0	2017-10-26
PMA P960058S124 ADVANCED BIONICS	HiResolution Bionic Ear System	2017-10-25
PMA P960058S123 ADVANCED BIONICS	HiResolution Bionic Ear System	2017-10-05
PMA P960058S120 ADVANCED BIONICS	HiRESOLUTION BIONIC EAR SYSTEM	2017-05-17
PMA P960058S119 ADVANCED BIONICS	HiResolution Bionic Ear System	2016-11-29
PMA P960058S117 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM, HIRES ULTRA COCHLEAR IMPLANT WITH THE HIFOCUS MID-SCALA ELECTRODE	2016-07-15
PMA P960058S116 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-11-24
PMA P960058S118 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-09-18
PMA P960058S111 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-09-02
PMA P960058S114 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-08-14
PMA P960058S115 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-05-19
PMA P960058S112 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-05-19
PMA P960058S109 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2015-04-14
PMA P960058S113 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2014-12-12
PMA P960058S106 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM WITH THE NAIDA CI AQUACASE	2014-09-10
PMA P960058S108 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2014-07-29
PMA P960058S107 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2014-02-14
PMA P960058S105 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2014-01-08
PMA P960058S103 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2013-12-24
PMA P960058S104 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2013-09-18
PMA P960058S101 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2013-09-17
PMA P960058S102 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM WITH NAIDA CI Q70 SOUND PROCESSOR	2013-08-19
PMA P960058S099 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2013-08-19
PMA P960058S098 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2013-05-20
PMA P960058S100 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2013-03-12
PMA P960058S097 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2012-08-24
PMA P960058S096 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2012-08-20
PMA P960058S095 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2012-06-15
PMA P960058S091 ADVANCED BIONICS	AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2012-04-27
PMA P960058S094 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2012-04-02
PMA P960058S093 ADVANCED BIONICS	AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2012-03-12
PMA P960058S089 ADVANCED BIONICS	AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2011-11-17
PMA P960058S092 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2011-10-26
PMA P960058S090 ADVANCED BIONICS	AURIA HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2011-09-12
PMA P960058S087 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2010-12-14
PMA P960058S076 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2010-09-10
PMA P960058S085 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2010-08-24
PMA P960058S084 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2010-08-20
PMA P960058S080 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2010-06-11
PMA P960058S082 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2010-03-30
PMA P960058S081 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2009-06-12
PMA P960058S075 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2009-06-12
PMA P960058S079 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2009-03-18
PMA P960058S074 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2009-03-11
PMA P960058S078 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2009-03-05
PMA P960058S073 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2008-12-09
PMA P960058S070 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2008-10-31
PMA P960058S066 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2008-10-15
PMA P960058S061 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2008-04-21
PMA P960058S057 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2007-07-27
PMA P960058S058 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2007-07-02
PMA P960058S055 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2007-02-26
PMA P960058S049 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2006-08-17
PMA P960058S054 ADVANCED BIONICS	HARMONY HIRESOLUTION BIONIC EAR SYSTEM	2006-07-28
PMA P960058S047 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2006-04-11
PMA P960058S053 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2006-03-22
PMA P960058S050 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2006-01-17
PMA P960058S043 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2005-12-23
PMA P960058S048 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2005-12-05
PMA P960058S042 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2005-09-21
PMA P960058S045 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2005-07-25
PMA P960058S046 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2005-07-14
PMA P960058S040 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2005-03-07
PMA P960058S038 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2004-08-24
PMA P960058S036 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2004-08-04
PMA P960058S037 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2004-07-23
PMA P960058S034 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2004-07-19
PMA P960058S035 ADVANCED BIONICS	HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS	2004-05-14
PMA P960058S033 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2004-02-18
PMA P960058S032 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM	2003-12-16
PMA P960058S030 ADVANCED BIONICS	HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)	2003-07-07
PMA P960058S031 ADVANCED BIONICS	CII BIONIC CAR SYSTEM, HIRES AURIA PROCESSOR AND ACCESSORIES	2003-06-06
PMA P960058S029 ADVANCED BIONICS	CLARION CII BIONIC EAR SYSTEM	2003-02-04

Similar & Related FDA Registered Companies

• Advanced Bionics AG
• ADVANCED BIONICS28515 Westinghouse Placevalencia, CA 91355 PMA NumberP960058 Supplement NumberS156 Date Received08/12/2022 Decision Date09/09/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ADVANCED BIONICS28515 Westinghouse Placevalencia, CA 91355 PMA NumberP960058 Supplement NumberS155 Date Received07/13/2022 Decision Date08/11/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Advanced Bionics, LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080853698	Hong Kong,Hong Kong -> Long Beach, California	PLASTIC PACKING BOX	72 CTN
2020071148821	Hong Kong,Hong Kong -> Long Beach, California	PLASTIC PACKING BOX	72 CTN
2020011810104	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRICAL DRYING STATION INVOICE 1474155 HS-CODE 85167970 HBL BANQBRE4073833 . .	2 PKG
202001179147	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRICAL DRYING STATION INVOICE 1474155 HS-CODE 85167970 HBL BANQBRE4073833 . .	2 PKG
2019112754592	Hong Kong,Hong Kong -> Los Angeles, California	PLASTIC PACKING BOX H.S. CODE 3923 1000 (2160 PCS) 2 PLASTIC PLTS STC 72 CTNS . . .	72 CTN
2019112241674	Hong Kong,Hong Kong -> Los Angeles, California	PLASTIC PACKING BOX H.S. CODE 3923 1000 (2160 PCS) 2 PLASTIC PLTS STC 72 CTNS . . .	72 CTN
2019111952091	Hong Kong,Hong Kong -> Los Angeles, California	PLASTIC PACKING BOX H.S. CODE 3923 1000 (2160 PCS) 2 PLASTIC PLTS STC 72 CTNS . . .	72 CTN
2019111655733	Hong Kong,Hong Kong -> Los Angeles, California	PLASTIC PACKING BOX H.S. CODE 3923 1000 (2160 PCS) 2 PLASTIC PLTS STC 72 CTNS . . .	72 CTN