|
Device | DERMABOND(R) 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 | S003 |
Date Received | 04/10/2001 |
Decision Date | 11/19/2001 |
Reclassified Date
|
05/05/2008 |
Product Code |
MPN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A STATEMENT IN THE LABELING THAT THE DEIVCE PROVIDES MICROBIAL BARRIER PROPERTIES. |