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.
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. "
Device | DERMABOND TOPICAL SKIN ADHESIVE |
Generic Name | Tissue Adhesive For The Topical Approximation Of Skin |
Applicant | CLOSURE MEDICAL CORP. |
Date Received | 2003-10-09 |
Decision Date | 2003-12-01 |
PMA | P960052 |
Supplement | S007 |
Product Code | MPN |
Advisory Committee | General & Plastic Surgery |
Supplement Type | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | CLOSURE MEDICAL CORP. 5265 Capital Blvd. raleigh, NC 27616 |
Supplement Number | Date | Supplement Type |
---|---|---|
P960052 | Original 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) |