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 an additional sterilization facility and to another known method of sterilization located at sterigenics (formerly iba/griffith), charlotte, north carolina.
| Device | DERMABOND TOPICAL SKIN ADHESIVE |
| Generic Name | Tissue Adhesive For The Topical Approximation Of Skin |
| Applicant | CLOSURE MEDICAL CORP. |
| Date Received | 2004-08-19 |
| Decision Date | 2004-09-24 |
| PMA | P960052 |
| Supplement | S009 |
| Product Code | MPN |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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) |