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.

USA

NASDAQ

ABMD

DUNS 050636737

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

ABIOMED EUROPE GMBH

FDA Registration(s)

Registration Number	1220648
FEI Number	1220648
Name	ABIOMED, INC.
Owner & Operator	ABIOMED, INC.
Contact Address	22 CHERRY HILL DR. -- Danvers MA 01923 US
Official Correspondent	J. Kenneth Ryder x-978-6467017-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	22 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	Device	Date
GUDID 00813502013269 Abiomed, Inc.	Abiomed 14Fr Low Profile Introducer 1000458	2024-05-21
GUDID 00813502013474 Abiomed, Inc.	Impella 1000550	2023-11-06
GUDID 00813502012736 Abiomed, Inc.	Impella 1000535	2023-11-06
GUDID 00813502012729 Abiomed, Inc.	Impella 1000534	2023-11-06
GUDID 00813502012279 Abiomed, Inc.	Impella 1000080	2023-08-08
GUDID 00813502011876 Abiomed, Inc.	Impella 0048-0045	2023-08-08
GUDID 00813502011401 Abiomed, Inc.	Impella 0042-0040-US	2023-08-08
GUDID 00813502011388 Abiomed, Inc.	Impella 0048-0032	2023-08-08
GUDID 00813502012910 Abiomed, Inc.	Impella 1000441	2023-07-10
GUDID 04260113630259 Abiomed, Inc.	Impella 0042-0002	2023-06-27
GUDID 04260113630174 Abiomed, Inc.	Impella 005060	2023-06-27
GUDID 00813502013030 Abiomed, Inc.	Impella 1000432	2023-06-27
GUDID 00813502012828 Abiomed, Inc.	Impella 1000100	2023-06-27
GUDID 00813502012460 Abiomed, Inc.	Impella 1000200	2023-06-27
GUDID 00813502011869 Abiomed, Inc.	Impella 0046-0035	2023-06-27
GUDID 00813502010510 Abiomed, Inc.	Impella 0043-0002	2023-06-27
GUDID 00813502013252 Abiomed, Inc.	Impella 1000457	2023-06-08
GUDID 00813502012996 Abiomed, Inc.	Impella 1000434	2023-06-08
GUDID 00813502012811 Abiomed, Inc.	Impella RP Flex with SmartAssist	2023-02-23
PMN K222113 Abiomed Inc.	Abiomed 14Fr Low Profile Introducer Set	2022-10-13
PMA P170011S034 Abiomed, Inc.	Impella RP	2021-11-22
PMA P140003S089 ABIOMED, INC.	Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System	2021-11-22
PMA P140003S087 ABIOMED, INC.	Impella 5.5 with SmartAssist	2021-08-23
PMA P140003S083 ABIOMED, INC.	Impella Ventricular Support Systems	2021-07-13
PMA P140003S082 ABIOMED, INC.	Impella Left Ventricular Support Systems	2021-07-13
PMA P140003S081 ABIOMED, INC.	Impella Ventricular Support Systems	2021-07-13
PMA P170011S033 Abiomed, Inc.	Impella RP System	2021-07-12
PMA P170011S031 Abiomed, Inc.	Impella RP System	2021-07-09
PMA P170011S032 Abiomed, Inc.	Impella RP System	2021-06-28
PMA P170011S030 Abiomed, Inc.	Impella RP with SmartAssist System	2021-06-28
PMA P140003S080 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist	2021-06-28
PMA P170011S029 Abiomed, Inc.	Impella RP System	2021-06-15
PMA P140003S079 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD	2021-02-17
PMA P170011S028 Abiomed, Inc.	Impella RP	2020-11-06
PMA P140003S077 ABIOMED, INC.	Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD	2020-11-06
PMN K200109 Abiomed Inc.	OXY-1 System	2020-10-23
PMA P140003S075 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist.	2020-09-09
PMA P170011S025 Abiomed, Inc.	Impella RP System	2020-08-04
GUDID 00813502011791 Abiomed, Inc.	Impella® 23F x 30cm Sheath 0052-3069	2020-07-28
GUDID 00813502011784 Abiomed, Inc.	Impella® 23F x 6cm Axillary Sheath 0052-3068	2020-07-28
PMA P170011S024 Abiomed, Inc.	Impella RP System	2020-07-10
PMA P140003S073 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, Impella 5.0, and Impella LD Systems	2020-07-10
PMN K201116 Abiomed Inc.	Abiomed 23 Fr Sheath	2020-06-15
GUDID 00813502011715 Abiomed, Inc.	Impella 0052-0039	2020-04-23
GUDID 00813502011708 Abiomed, Inc.	Impella 0052-0038	2020-04-23
GUDID 00813502011661 Abiomed, Inc.	Impella 00523058	2020-04-23
GUDID 00813502011654 Abiomed, Inc.	Impella 00523057	2020-04-23
GUDID 00813502011531 Abiomed, Inc.	Impella 0550-0008	2020-04-23
GUDID 00813502011500 Abiomed, Inc.	Impella 0052356	2020-04-23
PMA P140003S070 ABIOMED, INC.	Automated Impella Controller	2020-04-17
PMA P170011S023 Abiomed, Inc.	Impella RP	2020-04-09
PMA P140003S071 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD	2020-04-09
PMA P170011S021 Abiomed, Inc.	Impella RP System	2020-04-01
PMA P170011S022 Abiomed, Inc.	Impella RP System	2020-03-30
PMA P140003S069 ABIOMED, INC.	Impella CP with SmartAssist	2020-02-28
PMA P170011S020 Abiomed, Inc.	Impella RP System	2020-01-24
PMA P140003S066 ABIOMED, INC.	IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and	2020-01-22
PMN K192769 \| DYB ABIOMED, INC.	Impella CP Introducer	2020-01-21
PMA P140003S064 ABIOMED, INC.	Impella 5.5 with SmartAssist	2019-11-28
PMA P170011S019 Abiomed, Inc.	Impella RP System	2019-11-25
PMA P140003S063 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD	2019-11-25
PMA P170011S018 Abiomed, Inc.	Impella RP	2019-11-20
PMA P140003S062 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD	2019-11-20
PMN K192769 Abiomed, Inc.	Impella CP Introducer	2019-11-18
PMA P170011S017 Abiomed, Inc.	Impella RP System	2019-10-30
PMA P140003S061 ABIOMED, INC.	IMPELLA 2.5 System, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella 5.5 with SmartAssist and Impella LD	2019-10-30
PMA P170011S016 Abiomed, Inc.	Impella RP System	2019-10-03
PMA P140003S058 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems	2019-10-03
PMA P170011S014 Abiomed, Inc.	Impella RP System	2019-09-24
PMA P140003S056 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems	2019-09-24
PMA P140003S055 ABIOMED, INC.	Impella CP with SmartAssist	2019-07-03
PMA P170011S013 Abiomed, Inc.	Impella RP System	2019-06-28
PMA P170011S012 Abiomed, Inc.	Impella RP System	2019-06-28
PMA P140003S054 ABIOMED, INC.	Impella 5.0/LD	2019-06-28
PMA P140003S053 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0 and Impella LD Systems	2019-06-28
PMA P140003S052 ABIOMED, INC.	Impella CP with SmartAssist	2019-06-02
PMA P170011S011 Abiomed, Inc.	Impella RP	2019-05-21
PMA P140003S051 ABIOMED, INC.	IMPELLA 5.0 System	2019-05-06
PMA P140003S049 ABIOMED, INC.	Impella 5.0	2019-05-06
GUDID 00813502011371 Abiomed, Inc.	Impella 0048-0024	2019-04-26
PMA P170011S010 Abiomed, Inc.	Impella RP	2019-04-12
PMA P140003S048 ABIOMED, INC.	Impella 2.5	2019-03-20
PMA P140003S046 ABIOMED, INC.	Impella CP with SmartAssist	2019-03-03
PMA P140003S028 ABIOMED, INC.	Impella CP System	2019-01-09
PMA P140003S045 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems	2019-01-07
PMA P140003S043 ABIOMED, INC.	Impella CP with SmartAssist	2018-11-30
PMA P140003S042 ABIOMED, INC.	Impella CP with SmartAssist	2018-11-30
PMA P170011S008 Abiomed, Inc.	Impella RP System	2018-09-25
PMA P140003S040 ABIOMED, INC.	Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems	2018-09-25
PMA P140003S039 ABIOMED, INC.	Impella CP/Impella CP with SmartAssist	2018-09-07
PMA P140003S038 ABIOMED, INC.	Impella 2.5, Impella CP, Impella 5.0 and Impella LD	2018-08-28
PMA P170011S007 Abiomed, Inc.	Impella RP	2018-08-22
PMA P140003S037 ABIOMED, INC.	Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD	2018-08-22
PMA P170011S006 Abiomed, Inc.	Impella RP	2018-08-10
PMA P140003S033 ABIOMED, INC.	Impella CP/LD, Impella 2.5/5.0	2018-07-10
GUDID 00813502011029 Abiomed, Inc.	Impella 004334	2018-07-06
GUDID 00813502010848 Abiomed, Inc.	AB5000 0507-0042	2018-07-06
GUDID 00813502010831 Abiomed, Inc.	AB5000 0507-0032	2018-07-06
GUDID 00813502010817 Abiomed, Inc.	AB5000 0506-1242-SV	2018-07-06
GUDID 00813502010800 Abiomed, Inc.	AB5000 0506-1242-SA	2018-07-06
GUDID 00813502010794 Abiomed, Inc.	AB5000 0506-1042-HV	2018-07-06
GUDID 00813502010787 Abiomed, Inc.	AB5000 0506-1042-HA	2018-07-06
GUDID 00813502010770 Abiomed, Inc.	AB5000 0506-1232-SV	2018-07-06
GUDID 00813502010763 Abiomed, Inc.	AB5000 0506-1232-SA	2018-07-06
GUDID 00813502010756 Abiomed, Inc.	AB5000 0506-1032-HV	2018-07-06
GUDID 00813502010749 Abiomed, Inc.	AB5000 0506-1032-HA	2018-07-06
GUDID 00813502010732 Abiomed, Inc.	AB5000 0506-0042M-VA	2018-07-06
GUDID 00813502010725 Abiomed, Inc.	AB5000 0506-0042MS-SA	2018-07-06
GUDID 00813502010718 Abiomed, Inc.	AB5000 0506-0042-AR	2018-07-06
GUDID 00813502010701 Abiomed, Inc.	AB5000 0506-0032M-VA	2018-07-06
GUDID 00813502010695 Abiomed, Inc.	AB5000 0506-0032MS-SA	2018-07-06
GUDID 00813502010688 Abiomed, Inc.	AB5000 0506-0010-SIL	2018-07-06
GUDID 00813502010671 Abiomed, Inc.	AB5000 0506-0010-HAR	2018-07-06
GUDID 00813502010404 Abiomed, Inc.	AB5000 0055-1242-SV	2018-07-06
GUDID 00813502010398 Abiomed, Inc.	AB5000 0055-1242-SA	2018-07-06
GUDID 00813502010381 Abiomed, Inc.	AB5000 0055-1232-SV	2018-07-06
GUDID 00813502010374 Abiomed, Inc.	AB5000 0055-1232-SA	2018-07-06
GUDID 00813502010367 Abiomed, Inc.	AB5000 0055-0042-SV	2018-07-06
GUDID 00813502010350 Abiomed, Inc.	AB5000 0055-1042-SA	2018-07-06
GUDID 00813502010343 Abiomed, Inc.	AB5000 005-1042-HV	2018-07-06
GUDID 00813502010336 Abiomed, Inc.	AB5000 005-1042-HAA	2018-07-06
GUDID 00813502010329 Abiomed, Inc.	AB5000 005-1042-HA	2018-07-06
GUDID 00813502010312 Abiomed, Inc.	AB5000 0055-1032-SV	2018-07-06
GUDID 00813502010305 Abiomed, Inc.	AB5000 0055-1032-SA	2018-07-06
GUDID 00813502010299 Abiomed, Inc.	AB5000 055-1032-HV	2018-07-06
GUDID 00813502010282 Abiomed, Inc.	AB5000 005-1032-HAA	2018-07-06
GUDID 00813502010275 Abiomed, Inc.	AB5000 0055-1032-HA	2018-07-06
GUDID 00813502010268 Abiomed, Inc.	AB5000 005-0042-MH	2018-07-06
GUDID 00813502010251 Abiomed, Inc.	AB5000 005-0032-MH	2018-07-06
PMA P140003S036 ABIOMED, INC.	Impella 5.0 System	2018-06-07
PMA P140003S035 ABIOMED, INC.	Impella 2.5 and Impella CP Ventricular Support Systems	2018-05-25
PMA P140003S034 ABIOMED, INC.	Impella 2.5, Impella CP Ventricular Support Systems	2018-05-24
PMA P140003S032 ABIOMED, INC.	Impella 2.5 and Impella CP Ventricular Support System	2018-05-18
PMA P140003S030 ABIOMED, INC.	Impella CP with SmartAssist	2018-05-02
PMA P170011S005 Abiomed, Inc.	Impella RP System	2018-04-30
PMA P140003S029 ABIOMED, INC.	Impella 2.5 System, Impella CP System, Impella CP Optical System, Impella 5.0 System, and Impella LD System	2018-04-30
PMA P140003S031 ABIOMED, INC.	Impella CP System	2018-04-16
GUDID 04260113630327 Abiomed, Inc.	Impella	2018-03-29
GUDID 04260113630310 Abiomed, Inc.	Impella	2018-03-29
GUDID 04260113630303 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502011364 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502011319 Abiomed, Inc.	Impella 0052-0002	2018-03-29
GUDID 00813502011302 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502011289 Abiomed, Inc.	Impella 0048-0003.0814	2018-03-29
GUDID 00813502011258 Abiomed, Inc.	Impella 0048-0003.0814	2018-03-29
GUDID 00813502011227 Abiomed, Inc.	Impella 005082	2018-03-29
GUDID 00813502011210 Abiomed, Inc.	Impella 004683	2018-03-29
GUDID 00813502011180 Abiomed, Inc.	Impella 005062	2018-03-29
GUDID 00813502011173 Abiomed, Inc.	Impella 004683	2018-03-29
GUDID 00813502011142 Abiomed, Inc.	Impella 0046-3030	2018-03-29
GUDID 00813502011135 Abiomed, Inc.	Impella 0043-0003	2018-03-29
GUDID 00813502011128 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502011081 Abiomed, Inc.	Impella 005042	2018-03-29
GUDID 00813502011067 Abiomed, Inc.	Impella 004672	2018-03-29
GUDID 00813502010480 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502010138 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502010114 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502010022 Abiomed, Inc.	Impella	2018-03-29
GUDID 00813502010015 Abiomed, Inc.	Impella	2018-03-29
GUDID 00081350201002 Abiomed, Inc.	Impella 0042-0000-US	2018-03-29
PMA P140003S026 ABIOMED, INC.	Impella CP System	2018-03-22
PMA P170011S003 Abiomed, Inc.	Impella RP System	2018-02-16
PMA P170011S002 Abiomed, Inc.	Impella RP System	2018-02-16
PMA P140003S027 ABIOMED, INC.	Impella 2.5 & Impella CP Systems	2018-02-08
PMA P140003S018 ABIOMED, INC.	Impella Ventricular Support Systems	2018-02-07
PMA P170011S004 Abiomed, Inc.	Impella RP System	2018-01-16
PMA P170011S001 Abiomed, Inc.	Impella RP System	2017-12-13
PMA P140003S025 ABIOMED, INC.	Automated Impella Controller	2017-11-27
PMN P170011 \| PYX ABIOMED, INC.	Impella RP	2017-11-09
PMA P140003S020 ABIOMED, INC.	Impella Ventricular Support System	2017-11-01
PMA P140003S023 ABIOMED, INC.	Impella 2.5 System and Impella Ventricular Support Sustems	2017-09-21
PMA P170011 Abiomed, Inc.	Impella RP System	2017-09-20
PMA P140003S017 ABIOMED, INC.	Impella 2.5, Impella CP Systems	2017-08-22
PMA P140003S024 ABIOMED, INC.	Impella Ventricular Support Systems	2017-08-21
PMA P140003S022 ABIOMED, INC.	Impella 2.5 and Impella CP Systems	2017-08-01
PMN P140003 \| OZD ABIOMED, INC.	Impella LD	2015-05-13
PMN P140003 \| OZD ABIOMED, INC.	Impella CP	2015-05-13
PMN P140003 \| OZD ABIOMED, INC.	Impella 5.0	2015-05-13
PMN P140003 \| OZD ABIOMED, INC.	Impella 2.5	2015-05-13
PMN P140003 \| OZD ABIOMED, INC.	Automated Impella Controller (AIC)	2015-05-13
PMN H140001 \| OJE ABIOMED, INC.	Impella RP	2015-05-11
OUG ABIOMED, INC.	Link Hospital MDDS	2014-05-15
PMN K112892 ABIOMED, INC.	IMPELLA 2.5 PLUS CATHETER	2012-09-06
PMN K110845 \| KFM ABIOMED, INC.	IMPELLA Controller with Flow Control	2011-06-09
PMN K110845 \| DWA ABIOMED, INC.	IMPELLA Controller with Flow Control	2011-06-09
PMN K110845 ABIOMED, INC.	IMPELLA CONTROLLER WITH FLOW CONTROL	2011-04-27
PMN K093801 ABIOMED, INC.	IMPELLA CONTROLLER	2010-07-08
PMN K083111 ABIOMED, INC.	IMPELLA 5.0 CATHETER FAMILY	2009-04-16
PMN K063723 ABIOMED, INC.	IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM	2008-05-30
PMN K070225 \| DSP ABIOMED, INC.	iPulse IABP Console	2007-12-27
PMN K070225 ABIOMED, INC.	SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE	2007-12-13
PMN P900023 \| DSQ ABIOMED, INC.	Surgical Accessories (Cannula, Cannula Graft and Sewing Cuff)	2007-12-06
PMN P900023 \| DSQ ABIOMED, INC.	BVS	2007-12-06
PMN P900023 \| DSQ ABIOMED, INC.	AB5000	2007-12-06
PMN P900023 \| DSQ ABIOMED, INC.	AB Portable Driver	2007-12-06
PMN H040006 \| LOZ ABIOMED, INC.	AbioCor	2007-12-06
PMN K062582 ABIOMED, INC.	SUPRACOR BALLOON CATHETER	2006-12-14
PMN K911643 ABIOMED, INC.	ABIODENT PERIOTEMP(R) SYSTEM	1991-07-09
EIL ABIOMED, INC.	PERIO TEMP ( TM)	1991-04-18
PMN K900574 ABIOMED, INC.	ABIOMED BODY LEAD ANALYZER MODEL 200/20	1990-03-15
PMN K885075 ABIOMED, INC.	ABIOMED PERIOTEMP(TM) PROBE	1989-02-13

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Related Finance Registrations

NCAGE Code	1LH63	ABIOMED, INC.
CAGE Code	1LH63	ABIOMED, INC.
S.A.M. Registration	1LH63 [50636737]	ABIOMED, INC.
SEC	0000815094	ABIOMED INC of DELAWARE