FDA.reportPublic FDA data

PMA P170011S022

Device
Impella RP System
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S022
Product code
PYX
Decision date
2020-03-30
Generic name
Temporary non-roller type right heart support blood pump
Approval order statement
Upgrade the laser welding workstation and associated Computer Numeric Control (CNC) program for the manufacture of the Pump Housing Assembly of the Impella RP catheter.

Current openFDA PMA Record#

Device
Impella RP System
Applicant
Abiomed, Inc.
PMA number
P170011
Supplement
S022
Product code
PYX
Generic name
Temporary non-roller type right heart support blood pump
Decision date
2020-03-30
Decision code
OK30
Date received
2020-03-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Upgrade the laser welding workstation and associated Computer Numeric Control (CNC) program for the manufacture of the Pump Housing Assembly of the Impella RP catheter.