FDA.reportPublic FDA data

PMA P170011S039

Device
Impella RP Flex with SmartAssist
Applicant
Abiomed, Inc.
Product code
PYX
Decision date
2022-10-28
Generic name
Temporary non-roller type right heart support blood pump
Approval order statement
Approval for the Impella RP Flex with SmartAssist which incorporates a new design to the cannula to allow for device placement via the internal jugular vein.

Current openFDA PMA Record#

Device
Impella RP Flex with SmartAssist
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S039
Product code
PYX
Generic name
Temporary non-roller type right heart support blood pump
Decision date
2022-10-28
Decision code
APPR
Date received
2022-03-31
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the Impella RP Flex with SmartAssist which incorporates a new design to the cannula to allow for device placement via the internal jugular vein.