LIPOSORBER LA-15 System
FDA premarket approval P910018/S027 · decided 2020-04-21
Approval details
- PMA number
- P910018
- Supplement
- S027
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LIPOSORBER LA-15 System
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2019-08-13
- Decision date
- 2020-04-21
- Days to decision
- 252 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for modification to the indications for use statement to include a new Group D - "Functional Hypercholesterolemic Heterozygotes with LDL-C >= 100 mg/dl and lipoprotein(a) [Lp(a)] >= 60 mg/dL, and either documented coronary artery disease or documented peripheral artery disease."
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