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 design change of the high viscosity dermabond applicator so that it has a reduced fill volume compared to the original high viscosity dermabond applicator (0. 325 grams rather than -. 565 grams of the original product). The device, high viscosity dermabond mini applicator, as modified, is indicated for? Topical application to hold closed approximated wound edges of trauma induced lacerations or surgical incisions, including punctures from minimally invasive surgery, that otherwise could be closed with sutures of u. S. P. Size 5-0 or smaller diameter, staples, or adhesive strips and that do not require4 topical medications after closure.?
| Device | HIGH VISCOSITY DERMABOND MINI APPLICATOR |
| Generic Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CLOSURE MEDICAL CORP. |
| Date Received | 2005-12-16 |
| Decision Date | 2006-02-10 |
| PMA | P960052 |
| Supplement | S011 |
| 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) |