|
Device | Impella 5.5 with SmartAssist |
Generic Name | Temporary non-roller type left heart support blood pump |
Applicant | ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 |
PMA Number | P140003 |
Supplement Number | S086 |
Date Received | 07/19/2021 |
Decision Date | 10/15/2021 |
Product Code |
OZD |
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 a revision of the Automated Impella Controller software related to the detection of obstructions of purge flow in the Impella 5.5 with Smart Assist. |