LIPOSORBER LA-15 System
FDA premarket approval P910018/S034 · decided 2022-06-30
Approval details
- PMA number
- P910018
- Supplement
- S034
- 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
- 2022-05-31
- Decision date
- 2022-06-30
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- This submission requests for a change in the material supplier of the NK-M3R(UL) which is a component device of the LIPOSORBER LA-15 System and one manufacturing process. The change is being made because the original supplier no longer produces the material.
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