PMA
P910018: LIPOSORBER(R) LA-15 SYSTEM ADSORPTION COLUMN, SULFUX(R) FS-05 PLASMA SEPARATOR, AND TUB. SYST. FOR PLASMAPHER. (LT-MA2).
FDA PMA · Lipoprotein, low density, removal · Kaneka Pharma America Corp.
Key facts
| PMA number | P910018 |
|---|---|
| Trade name | 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. |
| Owner/operator | KANEKA CORP. |
| Product code | MMY |
| Approval date | Feb 21, 1996 |
| Docket number | 96M-0193 |
| Notice date | Jul 1, 1996 |
| Establishment registration | 3031408734 |
| FEI number | 3031408734 |
At a glance
- 10–99 Supplements
- Jun 16, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: