Greatbatch Medical

Matched from indexed company URL: Greatbatch Ltd

FDA Registration(s)

Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2183787	2183787	Greatbatch Medical	1	Y	2026-01-01	2300 Berkshire Lane North Minneapolis MN US 55441
3011823740	3011823740	Greatbatch Medical S. de R.L. de C.V.	1	N	2026-01-01	Calle 5 Norte No. 511 Ciudad Industrial Tijuana Baja California MX 22444
3032867	3002755179	Greatbatch Medical	1	N	2020-04-25	9305 SW Nimbus Ave BEAVERTON OR US 97008

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
178499	1687139848	P920014	HEARTMATE VE LVAS	DSQ	1994-09-30
178499	1716913393	P870072	THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM	DSQ	1995-12-20
105721	2058007087	P130028	ALGOVITA SPINAL CORD STIMULATION SYSTEM	LGW	2015-11-20
105721	1262277686	P130012	MYOPORE SUTURELESS MYOCARDIAL PACING LEAD	DTB	2015-04-30
178499	2031594147	P100047	HEARTWARE VENTRICULAR ASSIST SYSTEM	DSQ	2012-11-20
178499	1095571320	P060040	THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM	DSQ	2008-04-21
178499	1979765150	P030011	SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)	LOZ	2004-10-15
105721	1376045052	K994097	MEDAMICUS EPIDURAL INTRODUCER	GZB	2000-03-01
105721	1195903387	K990705	MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET	DYB	1999-06-28
105721	1199765668	K965167	PERCUTANEOUS VENOUS INTRODUCER 10264	DYB	1997-07-25
178499	1575364074	K955628	FORE RUNNER EXTERNAL DEFIBRILLATOR/DEFIBRILLATOR PADS	MKJ	1996-09-10
105721	1595007207	K870562	DAIG PACEMAKER LEAD ADAPTOR	DTD	1987-03-03
105721	1584985788	K181855	RadialSeal Introducer Kit	DYB	2018-07-26
185359	1443769751	K152416	Indego	PHL	2016-02-26
178499	1034902761	K140551	PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR	MQB	2014-08-01
178499	1404044158	K133454	SONOSITE EDGE ULTRASOUND SYSTEM	IYN	2013-12-16
185359	1865336710	K132304	EPIQ DIAGNOSTIC ULTRASOUND SYSTEM	IYN	2013-08-21
178499	1270244777	K130849	INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450	MHX	2013-06-14
178499	1505406106	K130684	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	2013-10-18
105721	1364790016	K130559	MOBICATH BI-DIRECTIONAL GUIDING SHEATH	DYB	2013-05-24
178499	1261851024	K130464	CARESTREAM DRX-1 SYSTEM WITH DRX 2530C DETECTOR	MQB	2013-06-07
178499	1784024897	K130454	LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR	MKJ	2013-08-21
178499	1547436566	K130173	SONOSITE MAXX SERIES ULTRASOUND SYSTEM	IYN	2013-03-25
178499	1211049847	K123318	IDRIVE ULTRA POWERED HANDLE AND ENDO GIA ADAPTER	GDW	2012-12-18
178499	1173397714	K122600	LIFEPAK 1000 DEFIBRILLATOR	MKJ	2012-10-11
178499	1922844128	K122495	PERKINELMER XRD 1622 AP3 MED FLAT PANEL DETECTOR	MQB	2012-11-28
178499	1606789271	K121955	COUGHASSIST T70 DEVICE	NHJ	2012-12-14
178499	1707244982	K121510	IDRIVE ULTRA POWERED HANDLE ENDO GIA ADAPTER	GDW	2012-07-25
178499	1942559047	K113125	INTELLIVUE MX40 PATIENT MONITOR	DSI	2011-11-17
178499	1870829783	K112998	AUTOPULSE RESUSCITATION SYSTEM MODEL 1000	DRM	2012-03-15
178499	2003549619	K111693	PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	2011-10-28
178499	1112960305	K103700	ESSENTIAL MRI PATIENT MONITOR	DQA	2011-03-15
178499	1298177444	K103410	NEOPAP SYSTEM	BZD	2011-03-30
178499	1159890488	K103140	NICOLET WIRELESS EEG	GWL	2011-04-08
178499	1878440096	K102985	V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS	MNT	2011-04-05
185359	1749141254	K102972	LIFEPAK 12	MKJ	2010-12-22
105721	1044696742	K102540	PTFE PORTABLE INTRODUCER	DYB	2010-11-16
178499	1307488002	K102496	POWERHEART AED G3 SEMI-AUTOMATIC, POWERHEART AED G3 AUTOMATIC, POWERHEART AED G3 PRO, POWERHEART AED G3 PLUS	MKJ	2011-06-09
178499	1245623999	K102390	SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM	IYN	2010-11-19
185359	1538227850	K101797	SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T	LFL	2011-02-24
178499	1538227850	K101797	SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T	LFL	2011-02-24
178499	1682636777	K101643	MODEL LTV 1100 VENTILATOR	CBK	2011-01-26
105721	1893404854	K093232	OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER	DYB	2010-03-15
178499	1843001125	K090318	CARESTREAM DRX-1 SYSTEM	MQB	2009-04-06
178499	1453098481	K082660	V60 VENTILATOR, MODEL V8000	MNT	2009-01-09
105721	1993727036	K072248	VIAPEEL PEELABLE INTRODUCER	DYB	2007-11-09
105721	1977067929	K071574	STIFFER COAXIAL MICRO-INTRODUCER KIT	DYB	2007-07-05
178499	1166068060	K063375	HEARTSTART MRX, MODELS M3535A OR M3536A	MKJ	2007-01-11
105721	1800966947	K061119	ENPATH MEDICAL STEERABLE SHEATH	DQY	2006-05-18
178499	1769104389	K060167	ATRIA 3100, ATRIA 6100	DPS	2006-04-19
185359	1497540780	K053462	3160 MRI PATIENT MONITORING SYSTEM	MWI	2006-01-18
185359	1855522004	K052057	LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR	MKJ	2006-02-17
178499	1381523167	K051632	PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A	MKJ	2005-10-05
178499	1061560615	K050004	PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304	MKJ	2005-02-25
178499	1124459086	K040904	PHILIPS HEARTSTART HOME DEFIBRILLATOR, MODEL M5068A	NSA	2004-09-16
105721	1489964828	K040150	MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER	DYB	2004-02-18
178499	1192980027	K033275	LIFEPAK 12, 20, 500, CR PLUS	MKJ	2003-11-06
178499	1374483184	K021453	HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A	MKJ	2002-07-03
178499	1526783900	K020715	PHILIPS M5066A AND M5068A	MKJ	2002-11-08
185359	1960042341	K001725	HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A	MKJ	2000-09-08
105721	1409768626
185359	1438750187
178499	1456038500
105721	2003087468
185359	1065440017
105721	1102881330
105721	1107305176
185359	1342131699
185359	1374483184
185359	1381523167
105721	1485088702
185359	1538227850
105721	1551602542
185359	1608642372
105721	1692720362
185359	1733299750
105721	1854505483
185359	1862520893
105721	1868809997
185359	2031594147
105721	2034569076
185359	2039735505

Product Codes Associated With Registrations

Product code	Registration listing records	Latest decision
MKJ	15	2013-10-18
DYB	9	2018-07-26
MQB	4	2014-08-01
IYN	4	2013-12-16
DSQ	3	2012-11-20
GDW	2	2012-12-18
MNT	2	2011-04-05
LFL	2	2011-02-24
PHL	1	2016-02-26
LGW	1	2015-11-20
DTB	1	2015-04-30
MHX	1	2013-06-14
NHJ	1	2012-12-14
DRM	1	2012-03-15
DSI	1	2011-11-17
GWL	1	2011-04-08
BZD	1	2011-03-30
DQA	1	2011-03-15
CBK	1	2011-01-26
DQY	1	2006-05-18
DPS	1	2006-04-19
MWI	1	2006-01-18
LOZ	1	2004-10-15
NSA	1	2004-09-16
GZB	1	2000-03-01
DSQ	1	1994-09-30
DTD	1	1987-03-03

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...

200 records. Showing 1-40. Next

Greatbatch Medical

FDA Registration(s)

Registered Device Listings

Product Codes Associated With Registrations

PMA

PMN

GUDID