LIPOSORBER LA-15 System
FDA premarket approval P910018/S024 · decided 2018-03-26
Approval details
- PMA number
- P910018
- Supplement
- S024
- 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
- 2018-03-01
- Decision date
- 2018-03-26
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- New York, NY
- Statement
- Replacement of the annealing oven used in the manufacturing process of the hollow fibers for the SULFLUX® KP-05 device.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.