FDA.reportPublic FDA data

Greatbatch Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
21837872183787Greatbatch Medical1Y2026-01-012300 Berkshire Lane North Minneapolis MN US 55441
30118237403011823740Greatbatch Medical S. de R.L. de C.V.1N2026-01-01Calle 5 Norte No. 511 Ciudad Industrial Tijuana Baja California MX 22444
30328673002755179Greatbatch Medical1N2020-04-259305 SW Nimbus Ave BEAVERTON OR US 97008

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1784991687139848P920014HEARTMATE VE LVASDSQ1994-09-30
1784991716913393P870072THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEMDSQ1995-12-20
1057212058007087P130028ALGOVITA SPINAL CORD STIMULATION SYSTEMLGW2015-11-20
1057211262277686P130012MYOPORE SUTURELESS MYOCARDIAL PACING LEADDTB2015-04-30
1784992031594147P100047HEARTWARE VENTRICULAR ASSIST SYSTEMDSQ2012-11-20
1784991095571320P060040THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEMDSQ2008-04-21
1784991979765150P030011SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)LOZ2004-10-15
1057211376045052K994097MEDAMICUS EPIDURAL INTRODUCERGZB2000-03-01
1057211195903387K990705MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SETDYB1999-06-28
1057211199765668K965167PERCUTANEOUS VENOUS INTRODUCER 10264DYB1997-07-25
1784991575364074K955628FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADSMKJ1996-09-10
1057211595007207K870562DAIG PACEMAKER LEAD ADAPTORDTD1987-03-03
1057211584985788K181855RadialSeal Introducer KitDYB2018-07-26
1853591443769751K152416IndegoPHL2016-02-26
1784991034902761K140551PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTORMQB2014-08-01
1784991404044158K133454SONOSITE EDGE ULTRASOUND SYSTEMIYN2013-12-16
1853591865336710K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEMIYN2013-08-21
1784991270244777K130849INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450MHX2013-06-14
1784991505406106K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2013-10-18
1057211364790016K130559MOBICATH BI-DIRECTIONAL GUIDING SHEATHDYB2013-05-24
1784991261851024K130464CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTORMQB2013-06-07
1784991784024897K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORMKJ2013-08-21
1784991547436566K130173SONOSITE MAXX SERIES ULTRASOUND SYSTEMIYN2013-03-25
1784991211049847K123318IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTERGDW2012-12-18
1784991173397714K122600LIFEPAK 1000 DEFIBRILLATORMKJ2012-10-11
1784991922844128K122495PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTORMQB2012-11-28
1784991606789271K121955COUGHASSIST T70 DEVICENHJ2012-12-14
1784991707244982K121510IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTERGDW2012-07-25
1784991942559047K113125INTELLIVUE MX40 PATIENT MONITORDSI2011-11-17
1784991870829783K112998AUTOPULSE RESUSCITATION SYSTEM MODEL 1000DRM2012-03-15
1784992003549619K111693PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2011-10-28
1784991112960305K103700ESSENTIAL MRI PATIENT MONITORDQA2011-03-15
1784991298177444K103410NEOPAP SYSTEMBZD2011-03-30
1784991159890488K103140NICOLET WIRELESS EEGGWL2011-04-08
1784991878440096K102985V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONSMNT2011-04-05
1853591749141254K102972LIFEPAK 12MKJ2010-12-22
1057211044696742K102540PTFE PORTABLE INTRODUCERDYB2010-11-16
1784991307488002K102496POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUSMKJ2011-06-09
1784991245623999K102390SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEMIYN2010-11-19
1853591538227850K101797SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION TLFL2011-02-24
1784991538227850K101797SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION TLFL2011-02-24
1784991682636777K101643MODEL LTV 1100 VENTILATORCBK2011-01-26
1057211893404854K093232OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCERDYB2010-03-15
1784991843001125K090318CARESTREAM DRX-1 SYSTEMMQB2009-04-06
1784991453098481K082660V60 VENTILATOR, MODEL V8000MNT2009-01-09
1057211993727036K072248VIAPEEL PEELABLE INTRODUCERDYB2007-11-09
1057211977067929K071574STIFFER COAXIAL MICRO-INTRODUCER KITDYB2007-07-05
1784991166068060K063375HEARTSTART MRX, MODELS M3535A OR M3536AMKJ2007-01-11
1057211800966947K061119ENPATH MEDICAL STEERABLE SHEATHDQY2006-05-18
1784991769104389K060167ATRIA 3100, ATRIA 6100DPS2006-04-19
1853591497540780K0534623160 MRI PATIENT MONITORING SYSTEMMWI2006-01-18
1853591855522004K052057LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATORMKJ2006-02-17
1784991381523167K051632PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841AMKJ2005-10-05
1784991061560615K050004PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304MKJ2005-02-25
1784991124459086K040904PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068ANSA2004-09-16
1057211489964828K040150MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCERDYB2004-02-18
1784991192980027K033275LIFEPAK 12, 20, 500, CR PLUSMKJ2003-11-06
1784991374483184K021453HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735AMKJ2002-07-03
1784991526783900K020715PHILIPS M5066A AND M5068AMKJ2002-11-08
1853591960042341K001725HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735AMKJ2000-09-08
1057211409768626
1853591438750187
1784991456038500
1057212003087468
1853591065440017
1057211102881330
1057211107305176
1853591342131699
1853591374483184
1853591381523167
1057211485088702
1853591538227850
1057211551602542
1853591608642372
1057211692720362
1853591733299750
1057211854505483
1853591862520893
1057211868809997
1853592031594147
1057212034569076
1853592039735505

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MKJ152013-10-18
DYB92018-07-26
MQB42014-08-01
IYN42013-12-16
DSQ32012-11-20
GDW22012-12-18
MNT22011-04-05
LFL22011-02-24
PHL12016-02-26
LGW12015-11-20
DTB12015-04-30
MHX12013-06-14
NHJ12012-12-14
DRM12012-03-15
DSI12011-11-17
GWL12011-04-08
BZD12011-03-30
DQA12011-03-15
CBK12011-01-26
DQY12006-05-18
DPS12006-04-19
MWI12006-01-18
LOZ12004-10-15
NSA12004-09-16
GZB12000-03-01
DSQ 11994-09-30
DTD11987-03-03

PMA#

Myopore Sutureless Myocardial Pacing Lead

2022-12-12

Greatbatch Medical2300 Berkshire Lane Northminneapolis, MN 55441 PMA NumberP130012 Supplement NumberS010 Date Received08/08/2022 Decision Date12/12/2022 Product Code DTB  Advisory Committee Cardiovascular Supplement Type135 Review Track For 30-day Notice Su...

Myopore® Sutureless Myocardial Pacing Lead

2022-10-05

Greatbatch Medical2300 Berkshire Lane Northminneapolis, MN 55441 PMA NumberP130012 Supplement NumberS009 Date Received08/05/2022 Decision Date10/05/2022 Product Code DTB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proce...

PMN#