- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S036
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2025-01-15
- Decision code
- APPR
- Date received
- 2024-05-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- relocation of manufacturing site to KANEKA Corporation Tomatoh Plant 6-253, Kashiwabara, Tomakomai-Shi, Hokkaido, JAPAN. FEI 3031408734.