PMA P910018S033
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S033
- Product code
- MMY
- Decision date
- 2022-04-29
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Qualification of new equipment for the EVOH coating process and the Hollow Fiber (HF) drying process to increase hollow fiber production capacity.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S033
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2022-04-29
- Decision code
- OK30
- Date received
- 2022-03-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualification of new equipment for the EVOH coating process and the Hollow Fiber (HF) drying process to increase hollow fiber production capacity.