PMA P170011S014
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S014
- Product code
- PYX
- Decision date
- 2019-09-24
- Classification
- Temporary Non-roller Type Right Heart Support Blood Pump
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for the addition of information on heparin anticoagulation management to the Impella systems instructions for use (IFUs).
Current openFDA PMA Record#
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S014
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2019-09-24
- Decision code
- APPR
- Date received
- 2019-08-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the addition of information on heparin anticoagulation management to the Impella systems instructions for use (IFUs).