LIPOSORBER® LA-15 System
FDA premarket approval P910018/S036 · decided 2025-01-15
Approval details
- PMA number
- P910018
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIPOSORBER® LA-15 System
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2024-05-31
- Decision date
- 2025-01-15
- Days to decision
- 229 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- relocation of manufacturing site to KANEKA Corporation Tomatoh Plant 6-253, Kashiwabara, Tomakomai-Shi, Hokkaido, JAPAN. FEI 3031408734.
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