DERMABOND TOPICAL SKIN ADHESIVE

FDA Premarket Approval P960052 S012

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.

Pre-market Approval Supplement Details

Change to the sterilization process.

DeviceDERMABOND TOPICAL SKIN ADHESIVE
Generic NameTissue Adhesive For The Topical Approximation Of Skin
ApplicantCLOSURE MEDICAL CORP.
Date Received2006-08-16
Decision Date2006-09-14
PMAP960052
SupplementS012
Product CodeMPN 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CLOSURE MEDICAL CORP. 5265 Capital Blvd. raleigh, NC 27616

Supplemental Filings

Supplement NumberDateSupplement Type
P960052Original Filing
S012 2006-08-16 30-day Notice
S011 2005-12-16 Real-time Process
S010 2005-02-09 Real-time Process
S009 2004-08-19 Normal 180 Day Track No User Fee
S008
S007 2003-10-09 Special (immediate Track)
S006 2003-05-01 Real-time Process
S005 2002-06-27 Special (immediate Track)
S004 2001-05-01 Normal 180 Day Track
S003 2001-04-10 Normal 180 Day Track
S002 2001-03-12 Special (immediate Track)
S001 1999-06-09 Special (immediate Track)

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