PMA P910018S016
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S016
- Product code
- MMY
- Decision date
- 2012-06-19
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- CHANGE IN THE LOCATION OF A SUPPLIER¿S MANUFACTURING FACILITY THAT PRODUCES COMPONENTS USED IN THE MANUFACTURING OF THE DEVICE.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S016
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2012-06-19
- Decision code
- OK30
- Date received
- 2012-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE LOCATION OF A SUPPLIER¿S MANUFACTURING FACILITY THAT PRODUCES COMPONENTS USED IN THE MANUFACTURING OF THE DEVICE.