PMA P170011S056

Device: Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System;
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S056
Product code: PYX
Decision date: 2025-08-01
Classification: Cardiovascular
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: approval for modifying the Impella labeling to reflect the findings of the Impella Sodium Bicarbonate Post-Approval Study

Current openFDA PMA Record#

Device: Impella RP System; Impella RP with SmartAssist System; Impella RP Flex with SmartAssist System;
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S056
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2025-08-01
Decision code: APPR
Date received: 2025-02-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for modifying the Impella labeling to reflect the findings of the Impella Sodium Bicarbonate Post-Approval Study