PMA P910018S023
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S023
- Product code
- MMY
- Decision date
- 2019-03-28
- Classification
- Lipoprotein, Low Density, Removal
- Generic name
- Lipoprotein, low density, removal
- Approval order statement
- Approval for modifying the indications for use statement.
Current openFDA PMA Record#
- Device
- LIPOSORBER LA-15 System
- Applicant
- Kaneka Pharma America Corp.
- PMA number
- P910018
- Supplement
- S023
- Product code
- MMY
- Generic name
- Lipoprotein, low density, removal
- Decision date
- 2019-03-28
- Decision code
- APPR
- Date received
- 2018-02-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for modifying the indications for use statement.