Laura Dixon

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30073677323007367732Laura Dixon1N2026-01-01580 Howard Ave Somerset Somerset NJ US 08873

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
978181811903945K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSPFO2024-07-10
978181154904158K213733Ponto 5 SuperPowerLXB2021-12-16
978181040693343K211640Ponto 5 MiniLXB2021-08-10
978181712770292K203807Ponto Bone Anchored Hearing System, MONO Surgery KitMAH2021-03-03
978181539494141K190540Ponto 4LXB2019-05-02
978181974152085K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerLXB2016-09-29
978181720605804K152820Ponto Bone Anchored Hearing SystemMAH2016-01-22
978181045208399K152067Ponto bone anchored hearing systemMAH2015-11-23
978181967212233K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mmMAH2015-01-21
978181589909427K141616STERILIZATION CASSETTEKCT2014-09-23
978181707285181K132775PONTO PLUS AND PONTO PLUS POWERLXB2013-12-09
978181051945534K121228PONTO BONE ANCHORED HEARING SYSTEMMAH2012-09-07
978181408934710K112053OBC BONE ANCHORED HEARING SYSTEMMAH2011-11-18
978182040615184K103594PONTO PRO POWERLXB2011-06-15
978181623291895K090996PONTO PROLXB2009-07-29
978181534933468K082108OBC BONE ANCHORED HEARING AID SYSTEMLXB2008-11-14
978181042024672
978181159191040

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LXB82021-12-16
MAH62021-03-03
PFO12024-07-10
KCT12014-09-23