LIPOSORBER(R) LA-15 SYSTEM
FDA premarket approval P910018/S022 · decided 2017-05-23
Approval details
- PMA number
- P910018
- Supplement
- S022
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIPOSORBER(R) LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2017-03-31
- Decision date
- 2017-05-23
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for changes to the housing of adsorption column LA-15 and connector parts of tubing system NK-M3R(U), plus components of the LIPOSORBER® LA-15 System.
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