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 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.
| Device | HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE |
| Generic Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CLOSURE MEDICAL CORP. |
| Date Received | 2005-02-09 |
| Decision Date | 2005-03-21 |
| PMA | P960052 |
| Supplement | S010 |
| Product Code | MPN |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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) |