PMA P910018S026
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S026
- Product code
- MMY
- Decision date
- 2019-05-22
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Layout change of the manufacturing site for the LIPOSORBER LA-15 LDL Adsorption Column, a component of the LIPOSORBER LA-15 System device.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S026
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2019-05-22
- Decision code
- OK30
- Date received
- 2019-04-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Layout change of the manufacturing site for the LIPOSORBER LA-15 LDL Adsorption Column, a component of the LIPOSORBER LA-15 System device.