PMA P910018S024
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S024
- Product code
- MMY
- Decision date
- 2018-03-26
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Replacement of the annealing oven used in the manufacturing process of the hollow fibers for the SULFLUX® KP-05 device.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S024
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2018-03-26
- Decision code
- OK30
- Date received
- 2018-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Replacement of the annealing oven used in the manufacturing process of the hollow fibers for the SULFLUX® KP-05 device.