PMA supplement
BP940001 S003: CEPRATE SC Stem Cell Concentration System
FDA PMA supplement · Normal 180 Day Track · Nexell Therapeutics Inc.
Key facts
| Original PMA | BP940001 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Trade name | CEPRATE SC Stem Cell Concentration System |
| Generic name | Stem cell separation system |
| Applicant | Nexell Therapeutics Inc. |
| Product code | MZK |
| Received date | Oct 8, 1997 |
| Decision date | Jul 27, 1998 |
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: