FDA.reportPublic FDA data

Kathy Berg

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30084943153008377825Kathy Berg1N2026-01-018300 East Pacesetter Way Scottsdale AZ US 85255
30125525323012552532Kathy Berg1N2026-01-0115900 Valley View Ct Sylmar CA US 91342

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2008181609226794P970013MICRONY PACEMAKERSLWO2000-12-21
2008181949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
2008181615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
2008181405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
2008181461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
2238281461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
2008181346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
2008182051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
2008181326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
2238281364977690P130026TACTICATH QUARTZ SETOAE2014-10-24
2238281906099585P110016THERAPY COOL PATH DUO/ SAFIRE BLU DUO ABLATION CATHETER AND IBI 1500T9-CP V1.6 CARDIAC ABLATION GENERATOROAD2012-01-25
2008181599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
2238281599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
2008181539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
2238281284508201K230286Assert-IQ™ Insertable Cardiac MonitorMXC2023-05-17
2008181284508201K230286Assert-IQ™ Insertable Cardiac MonitorMXC2023-05-17
2008181410359388K212206Jot Dx Insertable Cardiac MonitorMXC2021-08-13
2008181984763745K202888Confirm Rx Insertable Cardiac MonitorMXC2020-11-23
2008181101566201K202876Confirm Rx Insertable Cardiac MonitorMXC2020-12-01
2238281071867675K201148EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software LicenseDQK2020-06-26
2008181163486185K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC2017-09-29
2008181657176303K130545MULTI LEAD TRIAL CABLEGZB2013-06-18
2238281406995437K090163STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078DRB2009-04-01
2238281454788660

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MXC62023-05-17
LWS31996-05-10
NIK22004-06-30
NVN21998-01-29
DQK12020-06-26
LWP12017-01-31
MHY12015-06-12
OAE12014-10-24
GZB12013-06-18
OAD12012-01-25
DRB12009-04-01
NKE12004-05-13
LWO12000-12-21
DXY11989-08-21