PMA
P860064: DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT
FDA PMA · CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL · C.R. Bard, Inc.
Key facts
| PMA number | P860064 |
|---|---|
| Trade name | DAVOL LONG TERM EPIDURAL CATHETER, CATHETER WITH VITACUFF ANTIMICROBIAL CUFF AND REPAIR KIT |
| Generic name | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Applicant | C.R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | LNY |
| Approval date | Feb 29, 1988 |
| Docket number | 88M-0092 |
| Notice date | May 3, 1988 |
| Establishment registration | 1018233 |
| FEI number | 1018233 |
At a glance
- 10–99 Supplements
- Dec 7, 2001 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: