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MEDTRONIC NEUROMODULATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21822072182207MEDTRONIC NEUROMODULATION1N2026-01-017000 Central Ave., N.E. Minneapolis MN US 55432

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1028641382056634P990034MEDTRONIC ISOMED INFUSION SYSTEMLKK2000-07-21
1028641865359843P970004MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROLEZW1997-09-29
1028641423819233P960009MEDTRONIC ACTIVA TREMOR CONTROL SYSTEMMHY1997-07-31
1028641458099229P860004MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEMLKK1988-03-14
1028641747154182P840001ITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYSLGW1984-11-30
1028641282547309P240011Medtronic Altaviva SystemQPT2025-09-18
1028641971537090P080025MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEMQON2011-03-14
1028641308615135K994097MEDAMICUS EPIDURAL INTRODUCERGZB2000-03-01
1028641171302462K960631MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OXGZF1996-05-21
1028641705595047K923567MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEADGZB1992-11-05
1028641177944408K132561NURO NEUROMODULATION SYSTEMNAM2013-11-05
1028641328357988K102523MULTI-LEAD TRIALING CABLE MODEL 355531GZB2010-10-26
1028641288591407K062041MODEL 3875 1 X 8 SC TEST STIMULATION LEADGZB2006-08-16
1028641491446915K051773MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADSGZB2005-07-28
1028641636234522K040568POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADSGZB2004-03-25
1028641423989226K040334NAVIGUS PASSIVE PROBE, MODEL NP-1000HAW2004-10-04
1028641234865614K033619NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000HAW2004-03-02
1028641502487385K031885NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXXHBL2003-08-21
1028641984213119K022100NAVIGUS MANUAL DISPOSABLE MICRODRIVE WITH DIGITAL DISPLAY, MODELS MI-1000 & MI-1010HAW2002-09-25
1028641513233522K013120PERCUTANEOUS INTRODUCER SET, MODEL 042294 AND KIT MODEL 3550-18GZB2002-01-24
1028641452829244K012366NAVIGUS II TRAJECTORY GUIDEHAW2001-10-01
1028641055104641K001096BURR HOLE COVER, MODEL XXGXR2000-10-25
1028641519405913K000105MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38; MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),GZF2000-04-12
1028641001878378H990014
1028641456529414H050003
1028641490604411H020007
1028641591123371DEN210003SureTune4 SoftwareQQC2021-08-23
1028641085522967
1028641225235528
1028641669083042
1028641684260090
1028641743536426
1028641948594558

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZB72010-10-26
HAW42004-10-04
EZW22011-03-14
LKK22000-07-21
GZF22000-04-12
QQC12021-08-23
NAM12013-11-05
HBL12003-08-21
GXR12000-10-25
MHY11997-07-31
LGW11984-11-30

PMA#

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