PMA P170011S032
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S032
- Product code
- PYX
- Decision date
- 2021-06-28
- Generic name
- Temporary non-roller type right heart support blood pump
- Approval order statement
- Approval for the use of a new epoxy adhesive to manufacture Impella catheters.
Current openFDA PMA Record#
- Device
- Impella RP System
- Applicant
- Abiomed, Inc.
- PMA number
- P170011
- Supplement
- S032
- Product code
- PYX
- Generic name
- Temporary non-roller type right heart support blood pump
- Decision date
- 2021-06-28
- Decision code
- APPR
- Date received
- 2021-03-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the use of a new epoxy adhesive to manufacture Impella catheters.