BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S013 · decided 2010-06-18
Approval details
- PMA number
- P910018
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2009-10-27
- Decision date
- 2010-06-18
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT M.E. NIKKISO CO., LTD, CHACHEONGSAO, THAILAND.
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