LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
FDA premarket approval P910018 · decided 1996-02-21
Approval details
- PMA number
- P910018
- 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
- 1991-03-26
- Decision date
- 1996-02-21
- Days to decision
- 1793 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM. THE DEVICE IS A LOW DENSITY LIPOPROTEIN (LDL) APHERESIS SYTEM
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