PMA P960052S007

Device: DERMABOND TOPICAL SKIN ADHESIVE
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S007
Product code: MPN
Decision date: 2003-12-01
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: APPROVAL FOR A LABELING CHANGE TO MODIFY A WARNING STATEMENT (6TH BULLET) TO READ, "HIGH VISCOSITY DERMABOND ADHESIVE SHOULD NOT BE USED IN HIGH SKIN TENSION AREAS OR ACROSS AREAS OF INCREASED SKIN TENSION, SUCH AS KNUCKLES, ELBOWS, OR KNEES, UNLESS THE JOINT WILL BE IMMOBILIZED DURING THE SKIN HEALING PERIOD OR UNLESS SKIN TENSION HAS BEEN REMOVED BY APPLICATION OF ANOTHER WOUND CLOSURE DEVICE (E.G., SUTURES OR SKIN STAPLES) PRIOR TO THE APPLICATION OF HIGH VISCOSITY DERMABOND ADHESIVE."

Current openFDA PMA Record#

Device: DERMABOND TOPICAL SKIN ADHESIVE
Applicant: Closure Medical Corp.
PMA number: P960052
Supplement: S007
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2003-12-01
Decision code: APPR
Date received: 2003-10-09
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO MODIFY A WARNING STATEMENT (6TH BULLET) TO READ, "HIGH VISCOSITY DERMABOND ADHESIVE SHOULD NOT BE USED IN HIGH SKIN TENSION AREAS OR ACROSS AREAS OF INCREASED SKIN TENSION, SUCH AS KNUCKLES, ELBOWS, OR KNEES, UNLESS THE JOINT WILL BE IMMOBILIZED DURING THE SKIN HEALING PERIOD OR UNLESS SKIN TENSION HAS BEEN REMOVED BY APPLICATION OF ANOTHER WOUND CLOSURE DEVICE (E.G., SUTURES OR SKIN STAPLES) PRIOR TO THE APPLICATION OF HIGH VISCOSITY DERMABOND ADHESIVE."