| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
| |
| Device | LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2). |
|---|
| Generic Name | Lipoprotein, low density, removal |
|---|
| Applicant | Kaneka Pharma America Corp.
546 Fifth Ave., 21st Floor
New York, NY 10036 |
|---|
| PMA Number | P910018 |
|---|
| Supplement Number | S037 |
|---|
| Date Received | 07/26/2024 |
|---|
| Decision Date | 03/05/2025 |
|---|
| Product Code |
MMY |
| Advisory Committee |
Gastroenterology/Urology |
|---|
| Supplement Type | Normal 180 Day Track |
|---|
| Supplement Reason | Change Design/Components/Specifications/Material |
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
| Predetermined Change Control Plan Authorized | No |
|---|
Approval Order Statement
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the above referenced premarket approval application (PMA) 180-day supplement(s)/75-day humanitarian device exemption (HDE) supplement(s), which requested approval for packaging material (the shape of the cap, removing one material (styrene elastomer) from the cap, and the welding of the cap to the device), labeling, and a new sterilization site at Kaneka Corporation Tomatoh Plant Tomakomai, Hokkaido, 059-1362 Japan. |
|
|
