This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
This device is indicated for topical application to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond(tm) may be used in conjunction with, but not in place of, subcuticular sutures.
| Device | DERMABOND (A FORMULATION OF 2-OCTYL CYANOACRYLATE) |
| Generic Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CLOSURE MEDICAL CORP. |
| Date Received | 1996-12-24 |
| Decision Date | 1998-08-26 |
| Notice Date | 1998-10-27 |
| PMA | P960052 |
| Supplement | S |
| Product Code | MPN |
| Docket Number | 98M-0879 |
| Advisory Committee | General & Plastic Surgery |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | CLOSURE MEDICAL CORP. 5265 Capital Blvd. raleigh, NC 27616 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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) |