MEDTRONIC ADVANCED ENERGY, LLC

Matched from indexed company URL: MEDTRONIC A

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1226420	3003017713	MEDTRONIC ADVANCED ENERGY, LLC	1	N	2020-04-25	180 INTERNATIONAL DRIVE Portsmouth NH US 03801
2135394	3003368396	MEDTRONIC AFT	1	N	2020-04-25	8200 Coral Sea Street Moundsview MN US 55112

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00763000865641	MR8 - TOOL MR8-23TD3010 MR8 23CM TWSTDRL3X10MM	+1(800)633-8766	Corporate.UDI@medtronic.com
00763000865658	MR8 - TOOL MR8-31TD3010 MR8 31CM TWSTDRL3X10MM	+1(800)633-8766	Corporate.UDI@medtronic.com

medtronic.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
157162	1973106752	K181257	PlasmaBlade X 3.0S, PlasmaBlade X 4.0	GEI	2018-08-02
157162	1267161922	K170381	Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini	GEI	2017-09-07
157162	1249238321	K170296	CoreCath 2.7S	GEI	2017-03-20
157162	1613408166	K152596	Intact® Gen2 System	KNW	2016-02-15
157162	1018042971	K150496	Total Knee Arthroplasty System	JWH	2015-06-12
157162	1010784335	K150297	PlasmaBlade UPPP and Suction Coagulator	GEI	2015-05-21
157162	2029062654	K143175	AEx Generator; PlasmaBlade T	GEI	2014-12-31
157162	1347855686	K142477	Intact Advance and Intact Excision XL, Intact BLES	KNW	2014-12-15
157162	1125330735	K132974	AQUAMANTYS 2.3 BIPOLAR SEALER, EVS 4.0 EPIDURAL VEIN SEALER, MINI EVS 3.4 EPIDURAL VEIN SEALER, SBS 5.0 SHEATHED BIPOLAR	GEI	2013-12-03
157162	1837210235	K123201	AQUAMANTYS ENDO DBS 8.7 DISSECTING BIPOLAR SEALER	GEI	2013-01-10
157162	1939061454	K111732	AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER	GEI	2011-12-05
157162	2051449725	K103775	PEAK SUCTION COAGULATOR	GEI	2011-05-27
157162	1347723578	K102709	PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE	GEI	2010-12-17
157162	1481850673	K102029	PEAK PULSAR II GENERATOR MODEL PS100-102	GEI	2010-12-16
157162	1483824909	K101057	AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1	GEI	2011-04-05
157162	1922460486	K093695	PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE	GEI	2010-04-13
157162	1678024225	K083415	PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE	GEI	2009-06-05
157162	1274194944	K082786	PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES	GEI	2008-12-03
157162	1637678464	K081057	INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL	KNW	2008-06-17
157162	1434546289	K073495	TISSUELINK AQUAMANTYS MALLEABLE BIPOLAR SEALER WITH LIGHT	GEI	2008-01-09
157162	1637614955	K073057	PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040	GEI	2008-07-22
5824	1767000610	K070311	CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261	GEI	2007-04-24
157162	1022725736	K063639	AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1	GEI	2007-02-22
157162	1141071256	K060413	INTACT BREAST LESION EXCISION SYSTEM AND ADVANCE	KNW	2006-04-27
5824	1514629171	K060400	CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000; CARDIOBLATE BP2 SURGICAL ABLATION DEVICE, MODEL 60831; CARDIOBLAT	GEI	2006-02-28
157162	1930064515	K053510	IR WIRELESS FOOT SWITCH	GEI	2006-03-20
157162	1388898615	K052859	AQUAMANTYS PUMP GENERATOR SYSTEM	GEI	2005-10-25
5824	1465253070	K043291	CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884	GEI	2004-12-21
157162	1472458709	K014260	TISSUELINK SOLID CYLINDER MONOPOLAR DEVICE	GEI	2002-03-27
5824	1089548231	K013392	CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880	OCL	2002-01-25
157162	1759202062	K010662	MODIFICATION TO TISSUELINK MONOPOLAR FLOATING BALL	GEI	2001-04-27
157162	1473859133

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEI	25	2018-08-02
KNW	4	2016-02-15
JWH	1	2015-06-12
OCL	1	2002-01-25

PMA#

Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve – AP360

2022-10-21

MEDTRONIC ATS MEDICAL, INC.3800 Annapolis Lane, Suite 175plymouth, MN 55447 PMA NumberP990046 Supplement NumberS065 Date Received09/26/2022 Decision Date10/21/2022 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement R...

Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft

2022-03-11

MEDTRONIC ATS MEDICAL, INC.3800 Annapolis Lane, Suite 175plymouth, MN 55447 PMA NumberP990046 Supplement NumberS063 Date Received03/04/2022 Decision Date03/11/2022 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement R...

Open Pivot Heart Valve, Open Pivot Aortic Valved Graft

2022-03-10

MEDTRONIC ATS MEDICAL, INC.3800 Annapolis Lane, Suite 175plymouth, MN 55447 PMA NumberP990046 Supplement NumberS064 Date Received03/07/2022 Decision Date03/10/2022 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement R...

Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)

2022-03-10

MEDTRONIC ATS MEDICAL, INC.3800 Annapolis Lane, Suite 175plymouth, MN 55447 PMA NumberP990046 Supplement NumberS062 Date Received02/08/2022 Decision Date03/10/2022 Product Code LWQ Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement R...

58 records. Showing 1-40. Next

GUDID#

MR8 - TOOL MR8-31TD3010 MR8 31CM TWSTDRL3X10MM

MEDTRONIC ABLATION FRONTIERS, LLC

2023-12-01

MR8 - TOOL MR8-23TD3010 MR8 23CM TWSTDRL3X10MM