PMA supplement
N5798 S004: OXYCEL
FDA PMA supplement · Bd Becton Dickinson Vacutainer Systems Preanalytic
Key facts
| Original PMA | N5798 |
|---|---|
| Supplement number | S004 |
| Trade name | OXYCEL |
| Generic name | Agent, absorbable hemostatic, non-collagen based |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Product code | LMG |
| Received date | Apr 21, 1983 |
| Decision date | Jun 3, 1983 |
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: