Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | HIGH VISCOSITY 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 | S010 |
Date Received | 02/09/2005 |
Decision Date | 03/21/2005 |
Reclassified Date
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05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
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