LIPOSORBER® LA-15 SYSTEM
FDA premarket approval P910018/S020 · decided 2016-09-23
Approval details
- PMA number
- P910018
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LIPOSORBER® LA-15 SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2016-04-20
- Decision date
- 2016-09-23
- Days to decision
- 156 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for a modification of the indications for use of the system.
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