PMA P140003S101
- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S101
- Product code
- OZD
- Decision date
- 2022-07-01
- Generic name
- Temporary non-roller type left heart support blood pump
- Approval order statement
- Additional supplier to clean and measure the insertion pins.
Current openFDA PMA Record#
- Device
- Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD
- Applicant
- Abiomed, Inc.
- PMA number
- P140003
- Supplement
- S101
- Product code
- OZD
- Generic name
- Temporary non-roller type left heart support blood pump
- Decision date
- 2022-07-01
- Decision code
- OK30
- Date received
- 2022-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional supplier to clean and measure the insertion pins.