PMA P140003S096
- Device
- Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- Product code
- OZD
- Decision date
- 2022-07-08
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Approval to update the Instructions for Use to incorporate results from the Impella PCCS PAS.
Current openFDA PMA Record#
- Device
- Impella 2.5, Impella CP & CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S096
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2022-07-08
- Decision code
- APPR
- Date received
- 2022-03-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval to update the Instructions for Use to incorporate results from the Impella PCCS PAS.