|
Device | Automated Impella Controller |
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 | S015 |
Date Received | 08/30/2019 |
Decision Date | 01/30/2020 |
Product Code |
PYX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design change for the Automated Impella Controller (AIC) carrier board. |