Abiomed Inc

FDA Filings

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

USANASDAQABMDDUNS 050636737

Abiomed Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1220648
FEI Number1220648
NameABIOMED, INC.
Owner & OperatorABIOMED, INC.
Contact Address22 CHERRY HILL DR. --
Danvers MA 01923 US
Official Correspondent
  • J. Kenneth Ryder
  • x-978-6467017-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address22 Cherry Hill Dr
DANVERS, MA 01923 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Abiomed, Inc.
Impella 0052-00392020-04-23
Abiomed, Inc.
Impella 0052-00382020-04-23
Abiomed, Inc.
Impella 005230582020-04-23
Abiomed, Inc.
Impella 005230572020-04-23
Abiomed, Inc.
Impella 0550-00082020-04-23
Abiomed, Inc.
Impella 00523562020-04-23
ABIOMED, INC.
Automated Impella Controller2020-04-17
Abiomed, Inc.
Impella RP2020-04-09
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD2020-04-09
Abiomed, Inc.
Impella RP System2020-04-01
Abiomed, Inc.
Impella RP System2020-03-30
ABIOMED, INC.
Impella CP with SmartAssist2020-02-28
Abiomed, Inc.
Impella RP System2020-01-24
ABIOMED, INC.
IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and2020-01-22
ABIOMED, INC.
Impella CP Introducer2020-01-21
ABIOMED, INC.
Impella 5.5 with SmartAssist2019-11-28
Abiomed, Inc.
Impella RP System2019-11-25
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD2019-11-25
Abiomed, Inc.
Impella RP2019-11-20
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD2019-11-20
Abiomed, Inc.
Impella CP Introducer2019-11-18
Abiomed, Inc.
Impella RP System2019-10-30
ABIOMED, INC.
IMPELLA 2.5 System, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella 5.5 with SmartAssist and Impella LD2019-10-30
Abiomed, Inc.
Impella RP System2019-10-03
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems2019-10-03
Abiomed, Inc.
Impella RP System2019-09-24
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems2019-09-24
ABIOMED, INC.
Impella CP with SmartAssist2019-07-03
Abiomed, Inc.
Impella RP System2019-06-28
Abiomed, Inc.
Impella RP System2019-06-28
ABIOMED, INC.
Impella 5.0/LD2019-06-28
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD Systems2019-06-28
ABIOMED, INC.
Impella CP with SmartAssist2019-06-02
Abiomed, Inc.
Impella RP2019-05-21
ABIOMED, INC.
IMPELLA 5.0 System2019-05-06
ABIOMED, INC.
Impella 5.02019-05-06
Abiomed, Inc.
Impella 0048-00242019-04-26
Abiomed, Inc.
Impella RP2019-04-12
ABIOMED, INC.
Impella 2.52019-03-20
ABIOMED, INC.
Impella CP with SmartAssist2019-03-03
ABIOMED, INC.
Impella CP System2019-01-09
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems2019-01-07
ABIOMED, INC.
Impella CP with SmartAssist2018-11-30
ABIOMED, INC.
Impella CP with SmartAssist2018-11-30
Abiomed, Inc.
Impella RP System2018-09-25
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems2018-09-25
ABIOMED, INC.
Impella CP/Impella CP with SmartAssist2018-09-07
ABIOMED, INC.
Impella 2.5, Impella CP, Impella 5.0 and Impella LD2018-08-28
Abiomed, Inc.
Impella RP2018-08-22
ABIOMED, INC.
Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD2018-08-22
Abiomed, Inc.
Impella RP2018-08-10
ABIOMED, INC.
Impella CP/LD, Impella 2.5/5.02018-07-10
Abiomed, Inc.
Impella 0043342018-07-06
Abiomed, Inc.
AB5000 0507-00422018-07-06
Abiomed, Inc.
AB5000 0507-00322018-07-06
Abiomed, Inc.
AB5000 0506-1242-SV2018-07-06
Abiomed, Inc.
AB5000 0506-1242-SA2018-07-06
Abiomed, Inc.
AB5000 0506-1042-HV2018-07-06
Abiomed, Inc.
AB5000 0506-1042-HA2018-07-06
Abiomed, Inc.
AB5000 0506-1232-SV2018-07-06
Abiomed, Inc.
AB5000 0506-1232-SA2018-07-06
Abiomed, Inc.
AB5000 0506-1032-HV2018-07-06
Abiomed, Inc.
AB5000 0506-1032-HA2018-07-06
Abiomed, Inc.
AB5000 0506-0042M-VA2018-07-06
Abiomed, Inc.
AB5000 0506-0042MS-SA2018-07-06
Abiomed, Inc.
AB5000 0506-0042-AR2018-07-06
Abiomed, Inc.
AB5000 0506-0032M-VA2018-07-06
Abiomed, Inc.
AB5000 0506-0032MS-SA2018-07-06
Abiomed, Inc.
AB5000 0506-0010-SIL2018-07-06
Abiomed, Inc.
AB5000 0506-0010-HAR2018-07-06
Abiomed, Inc.
AB5000 0055-1242-SV2018-07-06
Abiomed, Inc.
AB5000 0055-1242-SA2018-07-06
Abiomed, Inc.
AB5000 0055-1232-SV2018-07-06
Abiomed, Inc.
AB5000 0055-1232-SA2018-07-06
Abiomed, Inc.
AB5000 0055-0042-SV2018-07-06
Abiomed, Inc.
AB5000 0055-1042-SA2018-07-06
Abiomed, Inc.
AB5000 005-1042-HV2018-07-06
Abiomed, Inc.
AB5000 005-1042-HAA2018-07-06
Abiomed, Inc.
AB5000 005-1042-HA2018-07-06
Abiomed, Inc.
AB5000 0055-1032-SV2018-07-06
Abiomed, Inc.
AB5000 0055-1032-SA2018-07-06
Abiomed, Inc.
AB5000 055-1032-HV2018-07-06
Abiomed, Inc.
AB5000 005-1032-HAA2018-07-06
Abiomed, Inc.
AB5000 0055-1032-HA2018-07-06
Abiomed, Inc.
AB5000 005-0042-MH2018-07-06
Abiomed, Inc.
AB5000 005-0032-MH2018-07-06
ABIOMED, INC.
Impella 5.0 System2018-06-07
ABIOMED, INC.
Impella 2.5 and Impella CP Ventricular Support Systems2018-05-25
ABIOMED, INC.
Impella 2.5, Impella CP Ventricular Support Systems2018-05-24
ABIOMED, INC.
Impella 2.5 and Impella CP Ventricular Support System2018-05-18
ABIOMED, INC.
Impella CP with SmartAssist2018-05-02
Abiomed, Inc.
Impella RP System2018-04-30
ABIOMED, INC.
Impella 2.5 System, Impella CP System, Impella CP Optical System, Impella 5.0 System, and Impella LD System2018-04-30
ABIOMED, INC.
Impella CP System2018-04-16
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 0052-00022018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 0048-0003.08142018-03-29
Abiomed, Inc.
Impella 0048-0003.08142018-03-29
Abiomed, Inc.
Impella 0050822018-03-29
Abiomed, Inc.
Impella 0046832018-03-29
Abiomed, Inc.
Impella 0050622018-03-29
Abiomed, Inc.
Impella 0046832018-03-29
Abiomed, Inc.
Impella 0046-30302018-03-29
Abiomed, Inc.
Impella 0043-00032018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 0050422018-03-29
Abiomed, Inc.
Impella 0046722018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 2018-03-29
Abiomed, Inc.
Impella 0042-0000-US2018-03-29
ABIOMED, INC.
Impella CP System2018-03-22
Abiomed, Inc.
Impella RP System2018-02-16
Abiomed, Inc.
Impella RP System2018-02-16
ABIOMED, INC.
Impella 2.5 & Impella CP Systems2018-02-08
ABIOMED, INC.
Impella Ventricular Support Systems2018-02-07
Abiomed, Inc.
Impella RP System2018-01-16
Abiomed, Inc.
Impella RP System2017-12-13
ABIOMED, INC.
Automated Impella Controller2017-11-27
ABIOMED, INC.
Impella RP2017-11-09
ABIOMED, INC.
Impella Ventricular Support System2017-11-01
ABIOMED, INC.
Impella 2.5 System and Impella Ventricular Support Sustems2017-09-21
Abiomed, Inc.
Impella RP System2017-09-20
ABIOMED, INC.
Impella 2.5, Impella CP Systems2017-08-22
ABIOMED, INC.
Impella Ventricular Support Systems2017-08-21
ABIOMED, INC.
Impella 2.5 and Impella CP Systems2017-08-01
ABIOMED, INC.
Impella Ventricular Support Systems2017-07-14
ABIOMED, INC.
Impella CP Ventricular Support System2017-06-20
ABIOMED, INC.
Impella Ventricular Support Systems2017-04-17
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2017-04-14
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2017-01-31
ABIOMED, INC.
IMPELLA2017-01-25
ABIOMED, INC.
IMPELLA CP Systems2016-12-07
ABIOMED, INC.
IMPELLA VENTRICULAR SUPPORT SYSTEM2016-12-01
ABIOMED, INC.
IMPELLA CP SYSTEM2016-11-03
ABIOMED, INC.
Impella Ventricular Support Systems2016-08-09
ABIOMED, INC.
IMPELLA VENTRICULAR SUPPORT SYSTEMS2016-08-09
ABIOMED, INC.
IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM2016-04-07
ABIOMED, INC.
IMPELLA VENTRICULAR SUPPORT SYSTEMS2016-04-07
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2016-01-25
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2015-11-13
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2015-11-03
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2015-07-08
ABIOMED, INC.
IMPELLA 2.5 SYSTEM2015-06-17
ABIOMED, INC.
Impella LD2015-05-13
ABIOMED, INC.
Impella CP2015-05-13
ABIOMED, INC.
Impella 5.02015-05-13
ABIOMED, INC.
Impella 2.52015-05-13
ABIOMED, INC.
Automated Impella Controller (AIC)2015-05-13
ABIOMED, INC.
Impella RP2015-05-11
ABIOMED, INC.
IMPELLA 2.5 System2015-03-23
ABIOMED, INC.
Link Hospital MDDS2014-05-15
ABIOMED, INC.
IMPELLA 2.5 PLUS CATHETER2012-09-06
ABIOMED, INC.
IMPELLA Controller with Flow Control2011-06-09
ABIOMED, INC.
IMPELLA Controller with Flow Control2011-06-09
ABIOMED, INC.
IMPELLA CONTROLLER WITH FLOW CONTROL2011-04-27
ABIOMED, INC.
IMPELLA CONTROLLER2010-07-08
ABIOMED, INC.
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM2008-05-30
ABIOMED, INC.
iPulse IABP Console2007-12-27
ABIOMED, INC.
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE2007-12-13
ABIOMED, INC.
Surgical Accessories (Cannula, Cannula Graft and Sewing Cuff)2007-12-06
ABIOMED, INC.
BVS2007-12-06
ABIOMED, INC.
AB50002007-12-06
ABIOMED, INC.
AB Portable Driver2007-12-06
ABIOMED, INC.
AbioCor2007-12-06
ABIOMED, INC.
SUPRACOR BALLOON CATHETER2006-12-14
ABIOMED, INC.
ABIODENT PERIOTEMP(R) SYSTEM1991-07-09
ABIOMED, INC.
PERIO TEMP ( TM)1991-04-18
ABIOMED, INC.
ABIOMED BODY LEAD ANALYZER MODEL 200/201990-03-15
ABIOMED, INC.
ABIOMED PERIOTEMP(TM) PROBE1989-02-13

Similar & Related FDA Registered Companies

Related Finance Registrations

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.