PMA P910018S012
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S012
- Product code
- MMY
- Decision date
- 2009-03-31
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM USING THE MA-03 APHERESIS MACHINE AND THE BLOOD TUBING SYSTEMS; NK-M3R AND NK-M1R.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S012
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2009-03-31
- Decision code
- APPR
- Date received
- 2006-09-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE LIPOSORBER LA-15 SYSTEM USING THE MA-03 APHERESIS MACHINE AND THE BLOOD TUBING SYSTEMS; NK-M3R AND NK-M1R.