PMA P140003S127

Device: IMPELLA CP with Smart Assist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S127
Product code: OZD
Decision date: 2025-06-20
Classification: Cardiovascular
Generic name: Temporary non-roller type left heart support blood pump
Approval order statement: Approval for an update to the product labeling intended to strengthen the warnings related to a known device related adverse event, limb ischemia.

Current openFDA PMA Record#

Device: IMPELLA CP with Smart Assist
Applicant: Abiomed, Inc.
PMA number: P140003
Supplement: S127
Product code: OZD
Generic name: Temporary non-roller type left heart support blood pump
Decision date: 2025-06-20
Decision code: APPR
Date received: 2025-05-29
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an update to the product labeling intended to strengthen the warnings related to a known device related adverse event, limb ischemia.