LIPOSORBER LA-15 SYSTEM
FDA premarket approval P910018/S015 · decided 2012-05-03
Approval details
- PMA number
- P910018
- Supplement
- S015
- 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
- 2011-11-08
- Decision date
- 2012-05-03
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SULFLUX® KP-05 PLASMA SEPARATOR COMPONENT OF THE DEVICE.
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