PMA supplement
BP970001 S046: Isolex 300 Magnetic Cell Separation System
FDA PMA supplement · 135 Day Track for 30 Day Notification · Baxter Healthcare Corporation
Key facts
| Original PMA | BP970001 |
|---|---|
| Supplement number | S046 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | Isolex 300 Magnetic Cell Separation System |
| Generic name | Stem cell separation system |
| Applicant | Baxter Healthcare Corporation |
| Product code | MZK |
| Received date | May 8, 2008 |
| Decision date | Dec 4, 2008 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: