PRINEO SKIN CLOSURE SYSTEM
Device Facts
| Record ID | DEN090005 |
|---|---|
| Device Name | PRINEO SKIN CLOSURE SYSTEM |
| Applicant | Closure Medical Corp. |
| Product Code | OMD · General, Plastic Surgery |
| Decision Date | Apr 30, 2010 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 878.4011 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Regulatory Classification
Identification
A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.
Special Controls
*Classification.* Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.
