LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S005 · decided 2000-12-06
Approval details
- PMA number
- P910018
- Supplement
- S005
- 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
- 2000-06-20
- Decision date
- 2000-12-06
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR 1) REPLACING THE STERILIZATION DATE WITH THE ACTUAL EXPIRATION DATE, EXPRESSED AS MONTH AND YEAR, FOR THE LIPOSORBER(R) LA-15 SYSTEM COMPONENTS: LIPOSORBER(R) LA-15 COLUMN, SULFLUX(R) FS-05 PLASMA SEPARATOR, AND THE TUBING SYTEM FOR PLASMAPHERESIS LT-MA2; 2) REPLACING THE SLIP-TYPE MALE TUBING CONNECTORS WITH LUER-LOCK TYPE CONNECTORS ON THE SEPARATOR END-CAPS OF TE SULFLUX FS-05 PLASMA SEPARATOR; 3) MAKING THE FOLLOWING CHANGES TO THE TUBING SYSTEM FOR THE PLASMAPHERESIS LT-MA2: A)
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