PMA supplement
P860064 S009: DUPEN LONG TERM EPIDURAL CATHETER
FDA PMA supplement · Real-Time Process · C.R. Bard, Inc.
Key facts
| Original PMA | P860064 |
|---|---|
| Supplement number | S009 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | DUPEN LONG TERM EPIDURAL CATHETER |
| Generic name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Applicant | C.R. Bard, Inc. |
| Product code | LNY |
| Received date | Jan 15, 1998 |
| Decision date | Jan 26, 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: