PMA P910018S030
- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S030
- Product code
- MMY
- Decision date
- 2021-04-29
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Change in sterility tests for the SULFLUX KP-05 Plasma Separator.
Current openFDA PMA Record#
- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S030
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2021-04-29
- Decision code
- OK30
- Date received
- 2021-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in sterility tests for the SULFLUX KP-05 Plasma Separator.