PMA P170011S062
- Device
- Impella CP with SmartAssist; Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S062
- Product code
- PYX
- Decision date
- 2025-12-19
- Classification
- Cardiovascular
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- to change the clean room classification used for manufacturing at the Danvers, Massachusetts facility
Current openFDA PMA Record#
- Device
- Impella CP with SmartAssist; Impella 5.5 with SmartAssist
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S062
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2025-12-19
- Decision code
- OK30
- Date received
- 2025-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to change the clean room classification used for manufacturing at the Danvers, Massachusetts facility