|
Device | DERMABOND TOPICAL SKIN ADHESIVE (2-OCTYL CYANOACRYLATE) |
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 | S002 |
Date Received | 03/12/2001 |
Decision Date | 04/04/2001 |
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 TO MODIFY THE LABELING IN ORDER TO CLARIFY THE INSTRUCTIONS FOR PREPARING AND STORING THE DEVICE. |