LIPOSORBER LA-15 System
FDA premarket approval P910018/S023 · decided 2019-03-28
Approval details
- PMA number
- P910018
- Supplement
- S023
- 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
- 2018-02-16
- Decision date
- 2019-03-28
- Days to decision
- 405 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Approval for modifying the indications for use statement.
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