PMA
P050013: HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
FDA PMA · Tissue adhesive for the topical approximation of skin · Tissue Seal, LLC
Key facts
| PMA number | P050013 |
|---|---|
| Trade name | HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE |
| Generic name | Tissue adhesive for the topical approximation of skin |
| Applicant | Tissue Seal, LLC |
| Owner/operator | INTERNATIONAL TISSUE CO., LTD. |
| Product code | MPN |
| Approval date | Feb 16, 2007 |
| Docket number | 07M-0086 |
| Notice date | Mar 16, 2007 |
| Establishment registration | 3033952011 |
| FEI number | 3016734261 |
At a glance
- None Supplements
- Feb 16, 2007 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- No Withdrawn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: