PMA P960052S010

Device: HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S010
Product code: MPN
Decision date: 2005-03-21
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: APPROVAL FOR THE ADDITION OF PROPEN AND PROPEN XL APPLICATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HIGH VISCOSITY DERMABOND PROPEN TOPICAL ADHESIVE AND HIGH VISCOSITY DERMABOND PROPEN XL TOPICAL SKIN ADHESIVE PRODUCTS AND ARE INDICATED FOR TOPICAL APPLICATION 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. HIGH VISCOSITY DERMABOND PROPEN AND PROPEN XL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF SUBCUTICULAR SUTURES. DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF DEEP DERMAL STITCHES.

Current openFDA PMA Record#

Device: HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S010
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2005-03-21
Decision code: APPR
Date received: 2005-02-09
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF PROPEN AND PROPEN XL APPLICATORS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES HIGH VISCOSITY DERMABOND PROPEN TOPICAL ADHESIVE AND HIGH VISCOSITY DERMABOND PROPEN XL TOPICAL SKIN ADHESIVE PRODUCTS AND ARE INDICATED FOR TOPICAL APPLICATION 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. HIGH VISCOSITY DERMABOND PROPEN AND PROPEN XL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF SUBCUTICULAR SUTURES. DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF DEEP DERMAL STITCHES.