LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
FDA premarket approval P910018/S037 · decided 2025-03-05
Approval details
- PMA number
- P910018
- Supplement
- S037
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2024-07-26
- Decision date
- 2025-03-05
- Days to decision
- 222 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the above referenced premarket approval application (PMA) 180-day supplement(s)/75-day humanitarian device exemption (HDE) supplement(s), which requested approval for packaging material (the shape of the cap, removing one material (styrene elastomer) from the cap, and the welding of the cap to the device), labeling, and a new sterilization site at Kaneka Corporation Tomatoh
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