ABIOMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1220648	1220648	ABIOMED, INC.	1	N	2026-01-01	22 Cherry Hill Dr DANVERS MA US 01923

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00813502010022	Impella - Impella Controller, Packaged, US	978-646-1400	abm_csc_us@its.jnj.com
00813502010985	Impella - Impella Optical Controller, Packaged, US	978-646-1400	abm_csc_us@its.jnj.com
00813502011289	Impella - Impella Controller, Packaged, EU (For Loaners Only)	978-646-1400	abm_csc_us@its.jnj.com
00813502011401	Impella - Optical, AIC, Impella Connect, Pkgd, US	978-646-1400	abm_csc_us@its.jnj.com

its.jnj.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
1514	1655575937	P900023	ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEM	DSQ	1992-11-20
1514	1597260964	P170011	Impella RP System	PYX	2017-09-20
1514	1655437629	P140003	IMPELLA 2.5 System	OZD	2015-03-23
1514	1132770485	K223872	Low Profile Companion Sheath	DYB	2023-01-19
1514	1351705537	K223161	OXY-1 System	DTZ	2023-02-23
1514	1630841220	K222113	Abiomed 14Fr Low Profile Introducer Set	DYB	2022-10-13
1514	1966069776	K201116	Abiomed 23 Fr Sheath	DYB	2020-06-15
1514	1553661943	K192769	Impella CP Introducer	DYB	2019-11-18
1514	1283807568	K110845	IMPELLA CONTROLLER WITH FLOW CONTROL	KFM	2011-04-27
1514	1623168113	K070225	SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE	DSP	2007-12-13
1514	1180358046	H140001
1514	1162413697	H040006
1514	1408342763
1514	1279946487
1514	1736701679
1514	1781813537

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DYB	4	2023-01-19
DTZ	1	2023-02-23
PYX	1	2017-09-20
OZD	1	2015-03-23
KFM	1	2011-04-27
DSP	1	2007-12-13
DSQ	1	1992-11-20

PMA#

Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System
2021-11-22
ABIOMED, INC.
Impella RP
2021-11-22
Abiomed, Inc.
Impella 5.5 with SmartAssist
2021-08-23
ABIOMED, INC.
Impella Ventricular Support Systems
2021-07-13
ABIOMED, INC.
Impella Left Ventricular Support Systems
2021-07-13
ABIOMED, INC.
Impella Ventricular Support Systems
2021-07-13
ABIOMED, INC.
Impella RP System
2021-07-12
Abiomed, Inc.
Impella RP System
2021-07-09
Abiomed, Inc.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist
2021-06-28
ABIOMED, INC.
Impella RP System
2021-06-28
Abiomed, Inc.
Impella RP with SmartAssist System
2021-06-28
Abiomed, Inc.
Impella RP System
2021-06-15
Abiomed, Inc.
Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD
2021-02-17
ABIOMED, INC.
Impella RP
2020-11-06
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
ABIOMED, INC.
Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist.
2020-09-09
ABIOMED, INC.
Impella RP System
2020-08-04
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
ABIOMED, INC.
Impella RP System
2020-07-10
Abiomed, Inc.
Automated Impella Controller
2020-04-17
ABIOMED, INC.
Impella RP
2020-04-09
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
ABIOMED, INC.
Impella RP System
2020-04-01
Abiomed, Inc.
Impella RP System
2020-03-30
Abiomed, Inc.
Impella CP with SmartAssist
2020-02-28
ABIOMED, INC.
Impella RP System
2020-01-24
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
ABIOMED, INC.
Impella 5.5 with SmartAssist
2019-11-28
ABIOMED, INC.
Impella RP System
2019-11-25
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
ABIOMED, INC.
Impella RP
2019-11-20
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
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
ABIOMED, INC.
Impella RP System
2019-10-30
Abiomed, Inc.
Impella RP System
2019-10-03
Abiomed, Inc.
Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.0/LD Systems
2019-10-03
ABIOMED, INC.
Impella RP System
2019-09-24
Abiomed, Inc.
Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems
2019-09-24
ABIOMED, INC.
Impella CP with SmartAssist
2019-07-03
ABIOMED, INC.
Impella RP System
2019-06-28
Abiomed, Inc.

103 records. Showing 1-40. Next

PMN#

Abiomed 14Fr Low Profile Introducer Kit
2024-08-06
Abiomed, Inc.
preCARDIA Occlusion System
2023-06-30
Abiomed, Inc.
OXY-1 System
2023-02-23
Abiomed, Inc.
Impella XR Sheath Set
2020-12-07
Abiomed, Inc.
Impella CP Introducer
2019-11-18
Abiomed, Inc.
IMPELLA 2.5 PLUS CATHETER
2012-09-06
ABIOMED, INC.
IMPELLA CONTROLLER WITH FLOW CONTROL
2011-04-27
ABIOMED, INC.
IMPELLA CONTROLLER
2010-07-08
ABIOMED, INC.
IMPELLA 5.0 CATHETER FAMILY
2009-04-16
ABIOMED, INC.
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
2008-05-30
ABIOMED, INC.
SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE
2007-12-13
ABIOMED, INC.
SUPRACOR BALLOON CATHETER
2006-12-14
ABIOMED, INC.
ABIODENT PERIOTEMP(R) SYSTEM
1991-07-09
ABIOMED, INC.
ABIOMED BODY LEAD ANALYZER MODEL 200/20
1990-03-15
ABIOMED, INC.
ABIOMED PERIOTEMP(TM) PROBE
1989-02-13
ABIOMED, INC.

GUDID#

Impella - Impella Optical Controller, Packaged, US
Abiomed, Inc.
2023-08-08
Impella - Optical, AIC, Impella Connect, Pkgd, US
Abiomed, Inc.
2023-07-31
Impella - Impella Controller, Packaged, US
Abiomed, Inc.
2016-10-21
Impella - Impella Controller, Packaged, EU (For Loaners Only)
Abiomed, Inc.
2014-07-31
Abiomed Low Profile Introducer Kit - 14Fr Low Profile Introducer, 1UP, long (25cm)
Abiomed, Inc.
2026-01-12
Impella RP Flex Introducer Kit - Impella RP Flex Introducer Kit, 23Fr x 11cm
Abiomed, Inc.
2026-03-11
Abiomed Impella CP 14Fr Introducer Kit - Abiomed Impella CP 14Fr Introducer Kit, short (13cm)
Abiomed, Inc.
2026-03-11
Abiomed Impella CP 14Fr Introducer Kit - Abiomed Impella CP 14Fr Introducer Kit, Long (25cm)
Abiomed, Inc.
2026-03-11
Abiomed Impella14Fr Introducer Kit, 13cm & 25cm - Abiomed Impella CP 14Fr Introducer Kit, 13cm & 25cm
Abiomed, Inc.
2026-02-25
Impella CP with SmartAssist - Impella CP with SmartAssist (Pump 382) pump set
Abiomed, Inc.
2025-11-14
Impella 14Fr Introducer Kit, long - Impella Introducer Kit (14Fr, long)
Abiomed, Inc.
2025-10-16
Impella - Axillary Insertion Kit, PKGD
Abiomed, Inc.
2016-10-21
Impella - PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Abiomed, Inc.
2014-09-03
Impella - ABMD Intro Kit, 14Fr x Short, Pkgd US
Abiomed, Inc.
2023-10-27
Impella - ABMD Intro Kit, 14Fr x Long, Pkgd US
Abiomed, Inc.
2023-10-27
Impella - Impella CP C7 w V3 GWRU Set, US
Abiomed, Inc.
2023-07-31
Impella - Impella CP Pump 371 Set, US ( Impella CP with Smart Assist)
Abiomed, Inc.
2019-04-18
Impella - Pump 371 14F LT CMR Set
Abiomed, Inc.
2023-07-31
Abiomed 14Fr Low Profile Introducer - Kit, Low Profile, 14Fr, 25cm,Sheath Lock
Abiomed, Inc.
2024-05-13
Impella - Pump 381 Pump Set (US)
Abiomed, Inc.
2023-07-31
Impella - Kit, 14Fr Introducer, 13cm and 25cm
Abiomed, Inc.
2023-10-27
Impella - Introducer Kit 23Fr x 11cm
Abiomed, Inc.
2023-06-30
Impella - Kit, Low Profile, 14Fr, Short, 1UP
Abiomed, Inc.
2023-05-31
Impella - Kit, Low Profile, 14Fr, 13cm,Sheath Lock
Abiomed, Inc.
2023-05-31
Impella - ABMD 23Fr X 30cm Introducer Kit
Abiomed, Inc.
2020-07-20
Impella - ABMD Introducer Kit, 14Fr x Short, Pkgd
Abiomed, Inc.
2020-04-15
Impella - ABMD Introducer Kit, 14Fr x Long, Pkgd
Abiomed, Inc.
2020-04-15
Impella - 14Fr Introducer Kit
Abiomed, Inc.
2016-10-21
Impella - 23 Fr Introducer Kit
Abiomed, Inc.
2016-10-24
Impella - 13 Fr Introducer Kit
Abiomed, Inc.
2016-10-21
Impella - Purge Cassette Gen02, 5-Packs
Abiomed, Inc.
2023-06-19
Impella - Purge Cassette, Packaged
Abiomed, Inc.
2023-06-19
Impella - RP w Smart Assist Set, US
Abiomed, Inc.
2023-06-19
Impella - Purge Cassette Gen02, 5-Packs
Abiomed, Inc.
2023-06-19
Impella - Impella 5.5 with Smart Assist S2 Set, US
Abiomed, Inc.
2023-06-19
Impella - AIC w/Impella Connect for ECP
Abiomed, Inc.
2023-06-19
Impella - Impella 5.0 IMC Pump Set EU
Abiomed, Inc.
2023-06-19
Impella - Sterile Connector Cable Pump / IMC
Abiomed, Inc.
2023-06-19
Impella - Purge Cassette, 5 Pack
Abiomed, Inc.
2014-07-31
Impella - Packaged Slit Silicone Plugs (bx of 5)
Abiomed, Inc.
2014-07-31

94 records. Showing 1-40. Next