PMA P910018S038
- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S038
- Product code
- MMY
- Decision date
- 2024-08-27
- Classification
- Gastroenterology, Urology
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- a change in the endotoxin testing device for LIPOSORBER LA-15
Current openFDA PMA Record#
- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S038
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2024-08-27
- Decision code
- OK30
- Date received
- 2024-07-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the endotoxin testing device for LIPOSORBER LA-15