Liposorber LA-15 System
FDA premarket approval P910018/S025 · decided 2018-04-12
Approval details
- PMA number
- P910018
- Supplement
- S025
- 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
- 2018-03-29
- Decision date
- 2018-04-12
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Change to the bioburden recovery procedure of the sterilization process used for the SULFLUX® KP-05 plasma filter device, a component of the LIPOSORBER® LA-15 System.
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