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 two changes to the labeling: 1) change the instructions for use to state that two layers of adhesive should be applied instead of three layers and 2) the addition of language stating that the device can act as a barrier to microbial penetration when intact.
| Device | DERMABOND TOPICAL SKIN ADHESIVE |
| Generic Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CLOSURE MEDICAL CORP. |
| Date Received | 2003-05-01 |
| Decision Date | 2003-06-13 |
| PMA | P960052 |
| Supplement | S006 |
| Product Code | MPN |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Real-time Process |
| 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) |