|Approval Order Statement |
Approval for the design change of the high viscosity dermabond applicator so that it has a reduced fill volume compared to the original high viscosity dermabond applicator (0. 325 grams rather than -. 565 grams of the original product). The device, high viscosity dermabond mini applicator, as modified, is indicated for ?topical application to hold closed approximated wound edges of trauma induced lacerations or surgical incisions, including punctures from minimally invasive surgery, that otherwise could be closed with sutures of u. S. P. Size 5-0 or smaller diameter, staples, or adhesive strips and that do not require4 topical medications after closure. ?.