PMA P170011S019
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S019
- Product code
- PYX
- Decision date
- 2019-11-25
- Classification
- Temporary Non-roller Type Right Heart Support Blood Pump
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of Impella products.
Current openFDA PMA Record#
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S019
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2019-11-25
- Decision code
- OK30
- Date received
- 2019-10-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of Impella products.