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FDAMarket Authorization

[PMA Approved] Impella 2.5 System; Impella CP Syst — Abiomed, Inc. — P140003-S135

Feb 6, 2026
Decision Date: 2026-02-06Published: 2026-02-06Captured: 2026-02-24Abiomed, Inc.Device: Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart AProduct Code: OZD

FDA approved PMA P140003-S135 (decision: APPR). Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A by Abiomed, Inc..

  • •Trade name: Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5...
  • •Applicant: Abiomed, Inc.
  • •Decision: APPR
  • •Supplement type: Real-Time Process
  • •Product code: OZD
Decision:APPR
Device Class:3
Advisory Committee:CV
Supplement Type:Real-Time Process
Statement/Summary

approval for a modification to the Instructions for Use to allow sodium bicarbonate to be used in the purge fluid for the Impella catheters if heparin should not be used per the physician’s clinica...

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Impella 2.5 System; Impella CP System; Impella CP with Smart Assist System; Impella 5.0 System, Impella 5.5 with Smart A — Abiomed, Inc. | TrueMedDevice