LIPOSORBER LA-15 System
FDA premarket approval P910018/S040 · decided 2024-09-26
Approval details
- PMA number
- P910018
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIPOSORBER LA-15 System
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2024-08-30
- Decision date
- 2024-09-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Change in synthesis tank, timing of column bioburden reduction operation, and process automation including gel transfer operation, adjustment operation for gell filling volume, cap attachment operation, appearance inspection for final product release, transfer of intermediate products between processes.
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