Abiomed, Inc

FDA Filings

This page includes the latest FDA filings for Abiomed, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate

Latest Premarket Applications

PMAManufacturerDevice NameDate
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 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 System2019-10-30
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 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

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Impella
Abiomed, Inc.2019-04-26
Impella
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06
AB5000
Abiomed, Inc.2018-07-06

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