|
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 | S006 |
Date Received | 05/01/2003 |
Decision Date | 06/13/2003 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR TWO CHANGES TO THE LABELING: 1) CHANGE THE INSTRUCTIONS FOR USE TO STATE THAT TWO LAYERS OF ADHESIVE SHOULD BE APPLIED INSTEAD OF THREE LAYERS AND 2) THE ADDITION OF LANGUAGE STATING THAT THE DEVICE CAN ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN INTACT. |