PMA P170011S047

Device: Impella RP, Impella RP with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S047
Product code: PYX
Decision date: 2022-12-05
Generic name: Temporary non-roller type right heart support blood pump
Approval order statement: Approval for various modifications to the Instructions for Use to add the final results of Post-Approval Study (PAS) #1, Impella RP Real-World Evidence Evaluation and Periodic Reporting and to update the indications for use statement based on the PAS results.

Current openFDA PMA Record#

Device: Impella RP, Impella RP with SmartAssist
Applicant: Abiomed, Inc.
PMA number: P170011
Supplement: S047
Product code: PYX
Generic name: Temporary non-roller type right heart support blood pump
Decision date: 2022-12-05
Decision code: APPR
Date received: 2022-11-03
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for various modifications to the Instructions for Use to add the final results of Post-Approval Study (PAS) #1, Impella RP Real-World Evidence Evaluation and Periodic Reporting and to update the indications for use statement based on the PAS results.