PMA P170011S035

Device: Impella RP System, Impella RP with SmartAssist System
Applicant: Abiomed, Inc.
Product code: PYX
Decision date: 2022-04-19
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: Approval for revising the Instructions for Use to allow the use of sodium bicarbonate (25 or 50 mEq/L) as an alternative to heparin (25 or 50 U/mL) in the purge fluid during clinical use of the Impella catheters in patients intolerant to heparin or in whom heparin is contraindicated.

Current openFDA PMA Record#

Device: Impella RP System, Impella RP with SmartAssist System
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S035
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2022-04-19
Decision code: APPR
Date received: 2021-08-05
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for revising the Instructions for Use to allow the use of sodium bicarbonate (25 or 50 mEq/L) as an alternative to heparin (25 or 50 U/mL) in the purge fluid during clinical use of the Impella catheters in patients intolerant to heparin or in whom heparin is contraindicated.