FDA.reportPublic FDA data

PMA P140003S075

Device
Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist.
Applicant
Abiomed, Inc.
PMA number
P140003
Supplement
S075
Product code
OZD
Decision date
2020-09-09
Generic name
Temporary non-roller type left heart support blood pump
Approval order statement
Implementation of a semi-automated test fixture for the final qualification testing process for the Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist.

Current openFDA PMA Record#

Device
Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist.
Applicant
Abiomed, Inc.
PMA number
P140003
Supplement
S075
Product code
OZD
Generic name
Temporary non-roller type left heart support blood pump
Decision date
2020-09-09
Decision code
OK30
Date received
2020-08-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a semi-automated test fixture for the final qualification testing process for the Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist.