LIPOSORBER LA-15 System
FDA premarket approval P910018/S032 · decided 2022-01-14
Approval details
- PMA number
- P910018
- Supplement
- S032
- Supplement type
- Special (Immediate 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
- 2021-12-17
- Decision date
- 2022-01-14
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for modification to the labeling (within the Instructions for Use and Operators Manual) for the LIPOSORBER LA-15 System.
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