PMA P910018S020
- Device
- LIPOSORBER® LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S020
- Product code
- MMY
- Decision date
- 2016-09-23
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Approval for a modification of the indications for use of the system.
Current openFDA PMA Record#
- Device
- LIPOSORBER® LA-15 SYSTEM
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S020
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2016-09-23
- Decision code
- APPR
- Date received
- 2016-04-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification of the indications for use of the system.