LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S012 · decided 2009-03-31
Approval details
- PMA number
- P910018
- Supplement
- S012
- 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
- 2006-09-08
- Decision date
- 2009-03-31
- Days to decision
- 935 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 USING THE MA-03 APHERESIS MACHINE AND THE BLOOD TUBING SYSTEMS; NK-M3R AND NK-M1R.
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