PMA P910018S032
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S032
- Product code
- MMY
- Decision date
- 2022-01-14
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Approval for modification to the labeling (within the Instructions for Use and Operators Manual) for the LIPOSORBER LA-15 System.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S032
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2022-01-14
- Decision code
- APPR
- Date received
- 2021-12-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modification to the labeling (within the Instructions for Use and Operators Manual) for the LIPOSORBER LA-15 System.