PMA P910018S039
- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S039
- Product code
- MMY
- Decision date
- 2025-01-24
- Classification
- Gastroenterology, Urology
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- approval for changes to the Indications for Use Statement and device labeling.
Current openFDA PMA Record#
- Device
- LIPOSORBER® LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S039
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2025-01-24
- Decision code
- APPR
- Date received
- 2024-07-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for changes to the Indications for Use Statement and device labeling.