FDA.reportPublic FDA data

Medtronic Europe Sarl

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96144533002807576Medtronic Europe Sarl1N2027-01-01ROUTE DU MOLLIAU 31 Case Postale TOLOCHENAZ Vaud CH 1131

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
58061309515697P990001DIVA PLATFORM IMPLANTABLE PULSE GENERATORS AND PRO VIT APPLICATION SOFTWARE VERSION 3.3.2NVZ1999-09-27
58061877254910P980050MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOFLWS2000-06-14
58061232151429P980035MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARENVZ1999-01-29
58061178418077P980016VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORSLWS1998-10-09
58061528776185P900061MEDTRONIC PCD TACHYARRHYTHMIA CONTROL SYSTEMLWS1993-02-11
58062068263149P890003SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071NVZ1989-08-24
58061716070735P220012Aurora EV-ICD SystemLWS2023-10-20
58061912521580P150033MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEMPNJ2016-04-06
58061410889433P090013REVO MRI SURESCAN IPG AND PACING SYSTEMLWP2011-02-08
58062051129662P010031CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATIONNIK2002-06-26
58061950599349P010015MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEMLWP2001-08-28
58061305795452K212008Reveal LINQ Insertable Cardiac MonitorMXD2021-07-22
58061481378810K162855Reveal LINQMXD2017-02-23
58061333289263K160689Reveal LINQMXD2016-04-22
58061598622094K150117Medtronic Patient AsistantDSI2015-05-27
58061707672744K132649REVEAL LINQ INSERTABLE CARDIAC MONITORMXD2014-02-14
58061822859188K103764REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528DSI2011-05-04
58062014337383K071655REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538DSI2007-11-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MXD42021-07-22
DSI32015-05-27
LWS32000-06-14
LWP22011-02-08
NVZ21999-01-29
PNJ12016-04-06
NIK12002-06-26