LIPOSORBER LA-15 System
FDA premarket approval P910018/S028 · decided 2020-12-22
Approval details
- PMA number
- P910018
- Supplement
- S028
- 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
- 2020-11-27
- Decision date
- 2020-12-22
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Change in the sterilization bag supplier for the SULFLUX KP-05 Plasma Separator for the LIPOSORBER LA-15 System.
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