FDA.reportPublic FDA data

PMA P170011S052

Device
Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S052
Product code
PYX
Decision date
2023-12-21
Classification
Cardiovascular
Generic name
Temporary non-roller type right heart support blood pump
Approval order statement
approval for changes to the device labeling for the continued safe use of Impella catheters in regard to ventricular perforation and cotton fiber ingestion.

Current openFDA PMA Record#

Device
Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S052
Product code
PYX
Generic name
Temporary non-roller type right heart support blood pump
Decision date
2023-12-21
Decision code
APPR
Date received
2023-12-18
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
approval for changes to the device labeling for the continued safe use of Impella catheters in regard to ventricular perforation and cotton fiber ingestion.