LIPOSORBER LA-15 System
FDA premarket approval P910018/S029 · decided 2021-08-06
Approval details
- PMA number
- P910018
- Supplement
- S029
- Supplement type
- 135 Review Track For 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
- 2021-02-12
- Decision date
- 2021-08-06
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for the addition of the gel bioburden reduction tank, used for washing the cellulose gel material, to the manufacturing procedure for the LIPOSORBER LA-15 LDL Adsorption Column (LA-15 Column).
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