|
Device | DERMABOND TOPICAL SKIN ADHESIVE |
Generic Name | Tissue adhesive for the topical approximation of skin |
Regulation Number | 878.4010 |
Applicant | CLOSURE MEDICAL CORP. 5265 CAPITAL BLVD. RALEIGH, NC 27616 |
PMA Number | P960052 |
Supplement Number | S007 |
Date Received | 10/09/2003 |
Decision Date | 12/01/2003 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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." |