PMA P910018S013
- Device
- BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S013
- Product code
- MMY
- Decision date
- 2010-06-18
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT M.E. NIKKISO CO., LTD, CHACHEONGSAO, THAILAND.
Current openFDA PMA Record#
- Device
- BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S013
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2010-06-18
- Decision code
- APPR
- Date received
- 2009-10-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT M.E. NIKKISO CO., LTD, CHACHEONGSAO, THAILAND.