FDA.reportPublic FDA data

PMA P170011S023

Device
Impella RP
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S023
Product code
PYX
Decision date
2020-04-09
Generic name
Temporary non-roller type right heart support blood pump
Approval order statement
Implementing a semi-automated test fixture for the leakage current measurement test performed during the final inspection for the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, Impella LD, and Impella RP catheters.

Current openFDA PMA Record#

Device
Impella RP
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S023
Product code
PYX
Generic name
Temporary non-roller type right heart support blood pump
Decision date
2020-04-09
Decision code
OK30
Date received
2020-03-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementing a semi-automated test fixture for the leakage current measurement test performed during the final inspection for the Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, Impella LD, and Impella RP catheters.