|
Device | DERMABOND TOPICAL SKIN ADHESIVE |
Generic Name | Tissue adhesive for the topical approximation of skin |
Regulation Number | 878.4010 |
Applicant | CLOSURE MEDICAL CORP. 5265 CAPITAL BLVD. RALEIGH, NC 27616 |
PMA Number | P960052 |
Supplement Number | S001 |
Date Received | 06/09/1999 |
Decision Date | 02/15/2001 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING MODIFICATIONS TO CLARIFY SAFE USE OF THE PRODUCT. |