PMA supplement
BP970003 S001: DACS SC Kit
FDA PMA supplement · Normal 180 Day Track · Dendreon Corporation
Key facts
| Original PMA | BP970003 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Trade name | DACS SC Kit |
| Generic name | Stem cell separation system |
| Applicant | Dendreon Corporation |
| Product code | MZK |
| Received date | Jul 24, 2000 |
| Decision date | Jun 11, 2001 |
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: