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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceDERMABOND TOPICAL SKIN ADHESIVE
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantClosure Medical Corp.
5265 Capital Blvd.
Raleigh, NC 27616
PMA NumberP960052
Supplement NumberS009
Date Received08/19/2004
Decision Date09/24/2004
Reclassified Date05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL STERILIZATION FACILITY AND TO ANOTHER KNOWN METHOD OF STERILIZATION LOCATED AT STERIGENICS (FORMERLY IBA/GRIFFITH), CHARLOTTE, NORTH CAROLINA.
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