PMA
P960052: DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE)
FDA PMA · Tissue adhesive for the topical approximation of skin · Closure Medical Corp.
Key facts
| PMA number | P960052 |
|---|---|
| Trade name | DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE) |
| Generic name | Tissue adhesive for the topical approximation of skin |
| Applicant | Closure Medical Corp. |
| Product code | MPN |
| Approval date | Aug 26, 1998 |
| Docket number | 98M-0879 |
| Notice date | Oct 27, 1998 |
At a glance
- 10–99 Supplements
- Sep 14, 2006 Latest supplement decision
- No Withdrawn
- Yes 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: