Heartware Inc

FDA Filings

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

FDA Registration(s)
Registration Number3007042319
FEI Number3007042319
NameHeartWare, Inc.
Owner & OperatorMEDTRONIC INC.
Contact Address710 Medtronic Pkwy.
Minneapolis MN 55432 US
Official Correspondent
  • CHRISTINE - BOES
  • x-763-5260396-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address14400 NW 60th Ave
Miami Lakes, FL 33014 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
Heartware Inc.
 HVAD™ Controller 2025-09-08
Heartware Inc.
 HeartWare® Battery 1650DE2023-05-29
Heartware Inc.
 Explant Kit 17502023-04-20
Heartware Inc.
 HeartWare® Battery 1650DE2023-04-20
Heartware Inc.
 HVAD® Pump Surgical Tools – Extended Length 13282023-04-20
Heartware Inc.
 HVAD® Pump Surgical Tools 13182023-04-20
Heartware Inc.
 Data Cable 15752023-04-20
Heartware Inc.
 USB Flash Drive 15602023-04-20
Heartware Inc.
 Patient Pack 14752023-04-20
Heartware Inc.
 Alarm Adapter 14502023-04-20
Heartware Inc.
 HVAD® Controller 14202023-04-20
Heartware Inc.
 HVAD® Pump Outflow Graft 11252023-04-20
Heartware Inc.
 Data Cable 15752022-08-23
Heartware Inc.
 Alarm Adapter 14502022-08-23
Heartware Inc.
 HeartWare® Battery 1650DE2022-08-23
Heartware Inc.
 HeartWare® Controller DC Adapter 14402022-08-23
Heartware Inc.
 HeartWare® Monitor 1521US2022-08-23
Heartware Inc.
 HeartWare® Controller AC Adapter 1430US2022-08-23
Heartware Inc.
 HeartWare® Monitor AC Adapter 1555US2021-07-26
Heartware Inc.
 HVAD® Pump Implant Kit MCS1705PU2021-03-09
Heartware Inc.
 HVAD® Pump Outflow Graft MCS1725OG2020-12-22
Heartware Inc.
 HVAD® Pump Surgical Tools – Extended Length MCS1728ST2020-12-22
Heartware Inc.
 HVAD® Pump Surgical Tools MCS1718ST2020-12-22
Heartware Inc.
 HVAD® Pump Implant Accessories MCS1753AK2020-12-22
Heartware Inc.
 HVAD® Pump Implant Kit MCS1705PU2020-12-22
Heartware Inc.
 HeartWare® Battery A001582020-07-07
Heartware Inc.
 HeartWare® Controller DC Adapter A001572020-07-07
Heartware Inc.
 HeartWare® Battery A001562019-10-15
Heartware Inc.
 HeartWare® Controller AC Adapter A00155US2019-10-15
Heartware Inc.
 HVAD® Controller A00154US2019-10-15
Heartware Inc.
 HeartWare® Controller DC Adapter A001532019-10-15
Heartware Inc.
 HVAD Pump Implant Kit 11032018-11-22
Heartware Inc.
 HeartWare® Battery 1650DE2018-09-24
Heartware Inc.
 HeartWare® Battery 1650DE2018-09-24
Heartware Inc.
 HeartWare® Controller DC Adapter 14402018-07-06
Heartware Inc.
 HeartWare® Controller AC Adapter 1430US2018-07-06
Heartware Inc.
 HeartWare® Monitor AC Adapter 1555US2018-07-06
Heartware Inc.
 HeartWare® Battery 1650DE2018-07-06
Heartware Inc.
 HVAD® Pump Implant Kit 11032018-07-06
Heartware Inc.
 HeartWare® Monitor 1520US2018-07-06
Heartware Inc.
 HeartWare® Controller 1403US2018-07-06
Heartware Inc.
 Heartware® Monitor 1521US2018-07-06
Heartware Inc.
 HVAD® Pump Surgical Tools - Extended Length 13282018-07-06
Heartware Inc.
 HVAD® Controller 14202018-07-06
Heartware Inc.
 HeartWare® Battery 1650DE2018-07-06
Heartware Inc.
 HeartWare® Controller AC Adapter 1430US2018-07-06
Heartware Inc.
 HeartWare® Controller DC Adapter 14402018-07-06
Heartware Inc.
 HeartWare® Battery A000372018-03-29
Heartware Inc.
 HVAD® Pump Outflow Graft 11252018-03-29
Heartware Inc.
 Explant Kit 17502018-03-29
Heartware Inc.
 Data Cable 15752018-03-29
Heartware Inc.
 USB Flash Drive 15602018-03-29
Heartware Inc.
 HVAD® Pump Surgical Tools 13172018-03-29
Heartware Inc.
 Patient Pack 14752018-03-29
Heartware Inc.
 Alarm Adapter 14502018-03-29
Heartware Inc.
 HVAD® Pump Surgical Tools 13182018-03-29
Heartware Inc.
 HVAD® Pump Implant Accessories 11532018-03-29
Heartware Inc.
 HeartWare® Battery Charger 1600US2018-03-29
Heartware Inc.
 HeartWare® Monitor 1520US2018-03-29
Heartware Inc.
 HeartWare® Controller 1403US2018-03-29
Heartware Inc.
 HeartWare® Controller DC Adapter 14352018-03-29
Heartware Inc.
 HeartWare® Controller AC Adapter 1425US2018-03-29
Heartware Inc.
 HeartWare® Monitor AC Adapter 1555US2018-03-29
Heartware Inc.
 HeartWare® Battery 16502018-03-29
Heartware Inc.
 HVAD Pump Implant Kit 11032018-03-29
Heartware Inc.
 HeartWare® Shoulder Pack 2060US2018-03-29
Heartware Inc.
 HeartWare® Waist Pack 2050US2018-03-29
Heartware Inc.
 HeartWare® Shower Bag 2000US2018-03-29
Heartware Inc.
 Driveline Extension Cable 100US2018-03-29
Heartware Inc.
 HVAD® Pump Implant Kit (Enhanced) 11032018-03-29
HeartWare, Inc. [MEDTRONIC INC.]
HeartWare Ventricular Assist System2016-09-14
HEARTWARE, INC.
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM1997-10-16

Related Finance Registrations
NCAGE Code6U4C1HEARTWARE INC
CAGE Code6U4C1HEARTWARE INC
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092949831Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT LOADED AS 1 CARTON SHIPMENT NR 1284046 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION1 PKG
2020092445619Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT LOADED AS 1 CARTON SHIPMENT NR 1284046 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION1 PKG
2020092347034Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT LOADED AS 1 CARTON SHIPMENT NR 1284046 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION1 PKG
2020092268250Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT LOADED AS 1 CARTON SHIPMENT NR 1284046 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION1 PKG
202009125399Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT SHIPMENT NR 1264456 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS1 CTN
2020090412113Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT SHIPMENT NR 1264456 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS1 CTN
2020082528362Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT SHIPMENT NR 1264456 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS1 CTN
2020082232999Anvers,Belgium -> Charleston, South CarolinaSTC MEDICAL EQUIPMENT SHIPMENT NR 1264456 CONTAINS HARMLESS LITHIUM BATTERIES CONTENT AND DETAILS AS PER SHIPPER S DECLARATION LOADED IN SACO CHS1 CTN
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