PMA P960052S004

Device: DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S004
Product code: MPN
Decision date: 2002-12-31
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: APPROVAL FOR THE ADDITION OF A HIGHER VISCOSITY PRODUCT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE AND IS INTENDED 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. HIGH VISCOSITY DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.

Current openFDA PMA Record#

Device: DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S004
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2002-12-31
Decision code: APPR
Date received: 2001-05-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A HIGHER VISCOSITY PRODUCT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE AND IS INTENDED 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. HIGH VISCOSITY DERMABOND ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.