PMA P910018S007
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S007
- Product code
- MMY
- Decision date
- 2003-03-06
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- APPROVAL FOR THE TRANSFER OF THE ASSEMBLY AND SOLDERING OF PRINTED CIRCUIT BOARDS USED IN CONJUNCTION WITH THE FINAL ASSEMBLY OF THE MA-01 APHERESIS MACHINE TO YOKOGAWA IBIDEN COMPONENTS CORPORAITON, OUME-CITY, TOKYO 198 JAPAN.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S007
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2003-03-06
- Decision code
- APPR
- Date received
- 2000-08-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR THE TRANSFER OF THE ASSEMBLY AND SOLDERING OF PRINTED CIRCUIT BOARDS USED IN CONJUNCTION WITH THE FINAL ASSEMBLY OF THE MA-01 APHERESIS MACHINE TO YOKOGAWA IBIDEN COMPONENTS CORPORAITON, OUME-CITY, TOKYO 198 JAPAN.