PMA P960052S011

Device: HIGH VISCOSITY DERMABOND MINI APPLICATOR
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S011
Product code: MPN
Decision date: 2006-02-10
Generic name: Tissue adhesive for the topical approximation of skin
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.?

Current openFDA PMA Record#

Device: HIGH VISCOSITY DERMABOND MINI APPLICATOR
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S011
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2006-02-10
Decision code: APPR
Date received: 2005-12-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.?