FDA.reportPublic FDA data

Advanced Bionics LLC

Matched from indexed company URL: Advanced Bionics

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30097626451000220815Advanced Bionics LLC1Y2026-01-0128515 Westinghouse Pl Valencia CA US 91355
30307843823030784382Advanced Bionics North American Operations Center S.A. de C.V.1N2026-01-01Avenida Riba 875, Parque Industrial Condesa Mexicali Baja California MX 21395
30065561153006556115Advanced Bionics LLC1N2020-04-2512740 San Fernando Rd Sylmar CA US 91342

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840094452329Zn-Air Battery Pak - Dragon Orange+1(661)362-1400xxx@xxx.xxx
00840094452404RF Cable - "5.5"" Black"+1(661)362-1400xxx@xxx.xxx
00840094452411RF Cable - "9.5"" Black"+1(661)362-1400xxx@xxx.xxx
00840094455382AB Remote - CI-6058-001+1(661)362-1400xxx@xxx.xxx
07630016863363UHP 2.0 Color Cap - Princess Pink+1(661)362-1400xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
783611970227506P960058CLARION MULTI-STRATEGY COCHLEAR IMPLANTMCM1997-06-26
1450401970227506P960058CLARION MULTI-STRATEGY COCHLEAR IMPLANTMCM1997-06-26
3332141970227506P960058CLARION MULTI-STRATEGY COCHLEAR IMPLANTMCM1997-06-26

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MCM31997-06-26

PMA#

HiResolution Bionic Ear System

2022-09-09

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 ...

HiResolution Bionic Ear System

2022-08-11

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 ...

149 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next