LIPOSORBER LA-15 System
FDA premarket approval P910018/S026 · decided 2019-05-22
Approval details
- PMA number
- P910018
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIPOSORBER LA-15 System
- Generic name
- Lipoprotein, low density, removal
- Applicant
- Kaneka Pharma America Corp.
- Date received
- 2019-04-23
- Decision date
- 2019-05-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Layout change of the manufacturing site for the LIPOSORBER LA-15 LDL Adsorption Column, a component of the LIPOSORBER LA-15 System device.
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