LIPOSORBER(R) LA-15 SYSTEM
FDA premarket approval P910018/S021 · decided 2016-10-14
Approval details
- PMA number
- P910018
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIPOSORBER(R) LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2016-07-29
- Decision date
- 2016-10-14
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for modifications to the instructions for use, operator's manual, and the patient guide for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and integration of instructions for use for the LIPOSORBER® LA-15 System for familial hypercholesterolemia and focal segmental glomerulosclerosis.
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