Greatbatch Medical

FDA Filings

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

FDA Registration(s)

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

FDA Filings

Device Company	Device	Date
PMA P130012S008 Greatbatch Medical	Myopore Sutureless Myocardial Pacing Lead	2019-07-03
PMA P130012S006 Greatbatch Medical	Myopore Sutureless Myocardial Pacing Lead	2019-02-21
PMA P130012S005 Greatbatch Medical	Myopore Sutureless Myocardial Pacing Lead	2018-09-25
PMN K181855 Greatbatch Medical	RadialSeal Introducer Kit	2018-07-26
PMA P130012S003 Greatbatch Medical	Myopore Sutureless Myocardial Pacing Lead	2017-06-08
PMA P130012S002 Greatbatch Medical	MYOPORE SUTURELESS MYOCARDIAL PACING LEAD	2016-09-27
PMA P130012S001 Greatbatch Medical	MYOPORE SUTURELESS MYOCARDIAL PACING LEAD	2016-09-19
PMA P130012 Greatbatch Medical	MYOPORE SUTURELESS MYOCARDIAL PACING LEAD	2015-04-30
PMN K130559 Greatbatch Medical	MOBICATH BI-DIRECTIONAL GUIDING SHEATH	2013-05-24
PMN K122832 Greatbatch Medical	MOBICATH TRANSSEPTAL NEEDLE	2012-12-19
PMN K112541 Greatbatch Medical	Z FLEX-270TM STEERABLE SHEATH	2012-02-07
PMN K110051 Greatbatch Medical	RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT	2012-02-02
PMN K111644 Greatbatch Medical	MOBICATH TRANSSEPTAL NEEDLE	2011-10-03
PMN K101784 Greatbatch Medical	MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX	2010-11-26
PMN K102540 Greatbatch Medical	PTFE PORTABLE INTRODUCER	2010-11-16
PMN K093232 Greatbatch Medical	OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER	2010-03-15
PMN K093023 Greatbatch Medical	PTFE PEELABLE INTRODUCER	2009-10-29

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

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020073143339	Shanghai ,China (Mainland) -> Los Angeles, California	LI ION BATTERY	600 CTN
2019082149356	Hong Kong,Hong Kong -> Long Beach, California	LI ION RECHARGEABLE BATTERY	13 CTN
2019082147499	Hong Kong,Hong Kong -> Long Beach, California	LITHIUM BATTERY MPE423048 3.7V 700MAH 30CARTO NS=1PALLET HS CODE: 8507600090	30 CTN
2019021332930	Yantian,China (Mainland) -> Los Angeles, California	LI-ION RECHARGEABLE BATTERY THIS SHIPMENT CO NTAINS NO SOLID WOOD PACKING MATERIALS	21 CTN
2018122144965	Yantian,China (Mainland) -> Los Angeles, California	LI-ION RECHARGEABLE BATTERY THIS SHIPMENT CO NTAINS NO SOLID WOOD PACKING MATERIALS	17 CTN
2018113040599	Yantian,China (Mainland) -> Los Angeles, California	LI-ION RECHARGEABLE BATTERY THIS SHIPMENT CO NTAINS NO SOLID WOOD PACKING MATERIALS	15 CTN
2018111536891	Yantian,China (Mainland) -> Los Angeles, California	LI-ION RECHARGEABLE BATTERY THIS SHIPMENT CO NTAINS NO SOLID WOOD PACKING MATERIALS	15 CTN
2018103144450	Shanghai ,China (Mainland) -> Los Angeles, California	TOP CASE ASSEMBLY SUNDANCE ROHS BOTTOM CASE SUNDANCE	101 CTN