|
Device | Impella RP and Impella RP with SmartAssist |
Generic Name | Temporary non-roller type right heart support blood pump |
Regulation Number | 870.4360 |
Applicant | Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
PMA Number | P170011 |
Supplement Number | S036 |
Date Received | 12/17/2021 |
Decision Date | 03/16/2022 |
Product Code |
PYX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternative luer to be used in the manufacture of the purge sidearm assembly. |