PMA P140003S056

Device: Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S056
Product code: OZD
Decision date: 2019-09-24
Classification: Temporary Non-roller Type Left Heart Support Blood Pump
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for the addition of information on heparin anticoagulation management to the Impella systems instructions for use (IFUs).

Current openFDA PMA Record#

Device: Impella 2.5, Impella CP, Impella CP with SmatAssist, Impella 5.0/LD Systems
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S056
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2019-09-24
Decision code: APPR
Date received: 2019-08-26
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the addition of information on heparin anticoagulation management to the Impella systems instructions for use (IFUs).