LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S001 · decided 1999-10-29
Approval details
- PMA number
- P910018
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIPOSORBER LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 1998-11-02
- Decision date
- 1999-10-29
- Days to decision
- 361 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for the following changes: 1) replacing the Membrane Filter Unit (MFU) located in the Liposorber LA-15 adsorption column, with the Cardioplegia Supor-1220 filter, which is bonded to the Extracoporeal Blood Tubing System, LT-MA2; 2) removing the maintenance unit and adding a clamp valve cover plate to the MA-01 Apheresis Unit; 3) making nine software changes, most of which are intended to either simplify procedures, ease the display of treatment parameters, or to make the therapy safer f
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