PMA P170011S007
- Device
- Impella RP
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S007
- Product code
- PYX
- Decision date
- 2018-08-22
- Classification
- Temporary Non-roller Type Right Heart Support Blood Pump
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Addition of an alternative biological indicator (BI) for the sterilization of all Impella family of catheters and the adoption of Impella CP with SmartAssist into the existing sterilization cycle for other Impella catheters at an alternate site.
Current openFDA PMA Record#
- Device
- Impella RP
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S007
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2018-08-22
- Decision code
- OK30
- Date received
- 2018-07-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative biological indicator (BI) for the sterilization of all Impella family of catheters and the adoption of Impella CP with SmartAssist into the existing sterilization cycle for other Impella catheters at an alternate site.