FDA.reportPublic FDA data

PMA P170011S050

Device
Impella RP Flex with SmartAssist
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S050
Product code
PYX
Decision date
2023-06-23
Classification
Cardiovascular
Generic name
Temporary non-roller type right heart support blood pump
Approval order statement
Approval for updates to the Instructions for Use (IFU) to include warning statements and clinical recommendations related to risk of thrombus formation or deposition in the Impella RP Flex with SmartAssist when indwelling venous lines or cannulas are present.

Current openFDA PMA Record#

Device
Impella RP Flex with SmartAssist
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S050
Product code
PYX
Generic name
Temporary non-roller type right heart support blood pump
Decision date
2023-06-23
Decision code
APPR
Date received
2023-05-26
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates to the Instructions for Use (IFU) to include warning statements and clinical recommendations related to risk of thrombus formation or deposition in the Impella RP Flex with SmartAssist when indwelling venous lines or cannulas are present.