Greatbatch L T D

FDA Filings

This page includes the latest FDA filings for Greatbatch L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Greatbatch L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Greatbatch Medical, S. de R.L. de C.V.
• Centro de Construccion de Cardioestimuladores del Uruguay S.
• Jeff Miller

FDA Registration(s)

• Registration Number: 3011823740
• FEI Number: 3011823740
• Name: Jeff Miller
• Owner & Operator: Greatbatch, Ltd.
• Contact Address: 100 Fordham Road --; Wilmington MA 01887 US
• US Agent:
  • Jeff Miller
  • Greatbatch Ltd.
  • 503 6154506
  • jeff.miller@integer.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9305 SW Nimbus Ave ; Beaverton, OR 97008 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3032867
• FEI Number: 3002755179
• Name: Greatbatch Medical
• Owner & Operator: Greatbatch, Ltd.
• Contact Address: 100 Fordham Road --; Wilmington MA 01887 US
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9305 SW Nimbus Ave ; BEAVERTON, OR 97008 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 2183787
• FEI Number: 2183787
• Name: Greatbatch Medical
• Owner & Operator: Greatbatch, Ltd.
• Contact Address: 100 Fordham Road --; Wilmington MA 01887 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2300 Berkshire Lane North ; Minneapolis, MN 55441 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

• Registration Number: 3010326622
• FEI Number: 3010326622
• Name: Centro de Construccion de Cardioestimuladores del Uruguay S.
• Owner & Operator: Greatbatch, Ltd.
• Contact Address: 100 Fordham Road --; Wilmington MA 01887 US
• US Agent:
  • Katherine Wilson
  • Greatbatch Ltd.
  • 763 9518206
  • katherine.wilson@integer.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: General Paz 1363 ; Montevideo Montevideo, 11400 UY
• Establishment Type:
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Sterilize Medical Device for Another Party (Contract Sterilizer)

• Registration Number: 3007882731
• FEI Number: 3007882731
• Name: Greatbatch Medical, S. de R.L. de C.V.
• Owner & Operator: Greatbatch, Ltd.
• Contact Address: 100 Fordham Road --; Wilmington MA 01887 US
• US Agent:
  • Katherine Wilson
  • Greatbatch Ltd.
  • 763 9518206
  • katherine.wilson@integer.net
• Importing Logistics Registration:
  • Importer: Greatbatch, Ltd.
  • Address: 10000 Wehrle Dr. ; Clarence, NY 14031 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Boulevard Hector Teran Teran #20120 Ciudad Industrial; Tijuana Baja California, 22444 MX
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 00821329400346 Greatbatch Ltd	Capella™ MK5183	2020-03-06
GUDID 00821329400339 Greatbatch Ltd	Capella™ MK5182	2020-03-06
GUDID 08714729862420 Greatbatch Ltd	Boston Scientific Channel Steerable Sheath M004CS200	2019-09-20
GUDID 08714729862413 Greatbatch Ltd	Boston Scientific Channel Steerable Sheath M004CS100	2019-09-20
GUDID 10821329600378 Greatbatch Ltd	ViaPeel™ 10893-002	2019-09-02
GUDID 10821329500074 Greatbatch Ltd	Flowguard™ 10684-005	2019-09-02
GUDID 10821329500029 Greatbatch Ltd	Flowguard™ 10684-002	2019-09-02
GUDID 10821329400411 Greatbatch Ltd	LI Plus 417675	2019-09-02
GUDID 10821329400398 Greatbatch Ltd	LI Plus 417673	2019-09-02
GUDID 10821329400381 Greatbatch Ltd	LI Plus 417672	2019-09-02
GUDID 20821329400845 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-28
GUDID 20821329400821 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329400814 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329400807 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329400791 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329400784 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329400777 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329400760 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329400753 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329400746 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329400739 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329001134 Greatbatch Ltd	OptiSeal™ 1003975-014	2019-08-23
GUDID 20821329001127 Greatbatch Ltd	OptiSeal™ 1003975-013	2019-08-23
GUDID 20821329001110 Greatbatch Ltd	OptiSeal™ 1003975-012	2019-08-23
GUDID 20821329001103 Greatbatch Ltd	OptiSeal™ 1003975-011	2019-08-23
GUDID 20821329001097 Greatbatch Ltd	OptiSeal™ 1003975-010	2019-08-23
GUDID 20821329001080 Greatbatch Ltd	OptiSeal™ 1003975-009	2019-08-23
GUDID 20821329001073 Greatbatch Ltd	OptiSeal™ 1003975-008	2019-08-23
GUDID 20821329001059 Greatbatch Ltd	OptiSeal™ 1003975-006	2019-08-23
GUDID 20821329001042 Greatbatch Ltd	OptiSeal™ 1003975-005	2019-08-23
GUDID 20821329001035 Greatbatch Ltd	OptiSeal™ 1003975-004	2019-08-23
GUDID 20821329001028 Greatbatch Ltd	OptiSeal™ 1003975-003	2019-08-23
GUDID 20821329001011 Greatbatch Ltd	OptiSeal™ 1003975-002	2019-08-23
GUDID 20821329001004 Greatbatch Ltd	OptiSeal™ 1003975-001	2019-08-23
GUDID 20821329000991 Greatbatch Ltd	OptiSeal™ 1000093-028	2019-08-23
GUDID 20821329000984 Greatbatch Ltd	OptiSeal™ 7452	2019-08-23
GUDID 20821329000977 Greatbatch Ltd	OptiSeal™ 7451	2019-08-23
GUDID 20821329000960 Greatbatch Ltd	OptiSeal™ 7450	2019-08-23
GUDID 20821329000946 Greatbatch Ltd	OptiSeal™ 7449	2019-08-23
GUDID 20821329000939 Greatbatch Ltd	OptiSeal™ 7448	2019-08-23
GUDID 20821329000922 Greatbatch Ltd	OptiSeal™ 7447	2019-08-23
GUDID 20821329000915 Greatbatch Ltd	OptiSeal™ 7446	2019-08-23
GUDID 20821329000908 Greatbatch Ltd	OptiSeal™ 7445	2019-08-23
GUDID 20821329000892 Greatbatch Ltd	OptiSeal™ 7444	2019-08-23
GUDID 20821329000885 Greatbatch Ltd	OptiSeal™ 7443	2019-08-23
GUDID 20821329000878 Greatbatch Ltd	OptiSeal™ 7442	2019-08-23
GUDID 20821329000861 Greatbatch Ltd	OptiSeal™ 7441	2019-08-23
GUDID 20821329000854 Greatbatch Ltd	OptiSeal™ 7440	2019-08-23
GUDID 20821329000847 Greatbatch Ltd	OptiSeal™ 1000093-014	2019-08-23
GUDID 20821329000823 Greatbatch Ltd	OptiSeal™ 1000093-012	2019-08-23
GUDID 20821329000816 Greatbatch Ltd	OptiSeal™ 1000093-011	2019-08-23
GUDID 20821329000809 Greatbatch Ltd	OptiSeal™ 1000093-010	2019-08-23
GUDID 20821329000793 Greatbatch Ltd	OptiSeal™ 1000093-009	2019-08-23
GUDID 20821329000786 Greatbatch Ltd	OptiSeal™ 1000093-008	2019-08-23
GUDID 20821329000779 Greatbatch Ltd	OptiSeal™ 1000093-007	2019-08-23
GUDID 20821329000762 Greatbatch Ltd	OptiSeal™ 1000093-006	2019-08-23
GUDID 20821329000755 Greatbatch Ltd	OptiSeal™ 1000093-005	2019-08-23
GUDID 20821329000748 Greatbatch Ltd	OptiSeal™ 1000093-004	2019-08-23
GUDID 20821329000731 Greatbatch Ltd	OptiSeal™ 1000093-003	2019-08-23
GUDID 20821329000724 Greatbatch Ltd	OptiSeal™ 1000093-002	2019-08-23
GUDID 20821329000700 Greatbatch Ltd	OptiSeal™ 1000092-004	2019-08-23
GUDID 20821329000694 Greatbatch Ltd	OptiSeal™ 1000092-003	2019-08-23
GUDID 20821329000687 Greatbatch Ltd	OptiSeal™ 1000092-002	2019-08-23
GUDID 20821329000670 Greatbatch Ltd	OptiSeal™ 1000092-001	2019-08-23
GUDID 20821329000489 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329000472 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329000465 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 20821329000458 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329000441 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 20821329000434 Greatbatch Ltd	RadialSeal™ Introducer Kit, SS Wire	2019-08-23
GUDID 10821329580434 Greatbatch Ltd	Algovita® 5510	2019-08-23
GUDID 10821329580427 Greatbatch Ltd	Algovita® 5500	2019-08-23
GUDID 10821329580403 Greatbatch Ltd	Algovita® 5400	2019-08-23
GUDID 10821329580397 Greatbatch Ltd	Algovita® 5310	2019-08-23
GUDID 10821329580380 Greatbatch Ltd	Algovita® 5300	2019-08-23
GUDID 00821329400834 Greatbatch Ltd	RadialSeal™ Introducer Kit, Poly Wire	2019-08-23
GUDID 00821329001062 Greatbatch Ltd	OptiSeal™ 1003975-007	2019-08-23
GUDID 00821329000713 Greatbatch Ltd	OptiSeal™ 1000093-001	2019-08-23
GUDID 20821329000830 Greatbatch Ltd	OptiSeal™ 1000093-013	2019-08-22
GUDID 00821329001666 Greatbatch Ltd	FasTac® Flex 6201 FAS	2019-08-20
GUDID 00821329001642 Greatbatch Ltd	FasTac® Flex 6201 FAS	2019-08-20
GUDID 00821329001635 Greatbatch Ltd	FasTac® Flex 6201 FAS	2019-08-20
GUDID 10821329000666 Greatbatch Ltd	Boston Scientific Channel Steerable Sheath M004CS200	2019-07-26
GUDID 00821329000652 Greatbatch Ltd	Boston Scientific Channel Steerable Sheath M004CS100	2019-07-26
GUDID 10821329000956 Greatbatch Ltd	PTFE Peelable Introducer Kit 7127	2019-06-07
GUDID 10821329000550 Greatbatch Ltd	PTFE Peelable Introducer Kit 7099	2019-06-07
GUDID 10821329000543 Greatbatch Ltd	PTFE Peelable Introducer Kit 7097	2019-06-07
GUDID 10821329000536 Greatbatch Ltd	PTFE Peelable Introducer Kit 7096	2019-06-07
GUDID 10821329000529 Greatbatch Ltd	PTFE Peelable Introducer Kit 7090	2019-06-07
GUDID 10821329000512 Greatbatch Ltd	PTFE Peelable Introducer Kit 7133	2019-06-07
GUDID 10821329000505 Greatbatch Ltd	PTFE Peelable Introducer Kit 7131	2019-06-07
GUDID 10821329000369 Greatbatch Ltd	PTFE Peelable Introducer Kit 7093	2019-06-07
GUDID 10821329000352 Greatbatch Ltd	PTFE Peelable Introducer Kit 7091	2019-06-07
GUDID 10821329000345 Greatbatch Ltd	PTFE Peelable Introducer Kit 7089	2019-06-07
GUDID 10821329000338 Greatbatch Ltd	PTFE Peelable Introducer Kit 7087	2019-06-07
GUDID 10821329000321 Greatbatch Ltd	PTFE Peelable Introducer Kit 7088	2019-06-07
GUDID 10821329000314 Greatbatch Ltd	PTFE Peelable Introducer Kit 7087	2019-06-07
GUDID 00821329001147 Greatbatch Ltd	PTFE Peelable Introducer Kit 7129	2019-06-07
GUDID 00821329000492 Greatbatch Ltd	PTFE Peelable Introducer Kit 7129	2019-06-07
GUDID 00821329000379 Greatbatch Ltd	PTFE Peelable Introducer Kit 7095	2019-06-07
HTO Greatbatch Medical, S. de R.L. de C.V. [Greatbatch, Ltd.]	Tissue Sparing Solutions Low Profile Reamer 66mm	1997-01-16

Similar & Related FDA Registered Companies

• 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 Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	2S554	GREATBATCH LTD
NCAGE Code	62713	GREATBATCH LTD.!DBA GREATBATCH MEDICAL!DIV ELECTROCHEM SOLUTIONS INC
CAGE Code	2S554	GREATBATCH LTD
CAGE Code	62713	GREATBATCH LTD. GREATBATCH MEDICAL ELECTROCHEM SOLUTIONS INC
S.A.M. Registration	62713 [58650102]	GREATBATCH LTD. GREATBATCH MEDICAL

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091018009	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	2 STEEL DRUMS (2PKGS) OF . 90274D PROPYLENE CARBONATE ELECTRO GRADE TANK-1 . 90275D DME(GLYME) ELECTROLYTE GRADE TANK-2	2 DRM
2020080670017	Taipei,China (Taiwan) -> Los Angeles, California	BASE BATTERY PACK VEGAS REV ARTWORK SHROUD BATTERY PACK VEGAS	90 CTN
2020080419124	Taipei,China (Taiwan) -> Los Angeles, California	BASE BATTERY PACK VEGAS SHROUD BATTERY PACK VEGAS ARTWORK	91 CTN
2020073026415	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	LITHIUM FOIL	39 DRM
2020072838244	Taipei,China (Taiwan) -> Los Angeles, California	BASE BATTERY PACK VEGAS SHROUD BATTERY PACK VEGAS ARTWORK	91 CTN
2020072363647	Taipei,China (Taiwan) -> Los Angeles, California	BASE BATTERY PACK VEGAS SHROUD BATTERY PACK VEGAS ARTWORK	91 CTN
2020072325132	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	LITHIUM FOIL	50 DRM
2020070315370	Taipei,China (Taiwan) -> Los Angeles, California	BASE BATTERY PACK VEGAS SHROUD BATTERY PACK VEGAS ARTWORK	46 CTN