PMA
P060029: ETHICON OMNEX SURGICAL SEALANT
FDA PMA · Sealant, polymerizing · ETHICON, Inc.
Key facts
| PMA number | P060029 |
|---|---|
| Trade name | ETHICON OMNEX SURGICAL SEALANT |
| Generic name | Sealant, polymerizing |
| Applicant | ETHICON, Inc. |
| Owner/operator | ETHICON INC. |
| Product code | NBE |
| Approval date | Jun 3, 2010 |
| Docket number | 10M-0285 |
| Notice date | Jun 11, 2010 |
| Establishment registration | 2210968 |
| FEI number | 2210968 |
At a glance
- 1–9 Supplements
- Jan 17, 2014 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: