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Device | HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE |
Generic Name | Tissue adhesive for the topical approximation of skin |
Regulation Number | 878.4010 |
Applicant | TISSUE SEAL LLC 5643 Plymouth Rd Ann Arbor, MI 48105 |
PMA Number | P050013 |
Date Received | 03/25/2005 |
Decision Date | 02/16/2007 |
Reclassified Date
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05/05/2008 |
Product Code |
MPN |
Docket Number | 07M-0086 |
Notice Date | 03/16/2007 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE. THE DEVICE IS INDICATED FOR TOPICAL APPLICATION TO HOLD CLOSED EASILY APPROXIMATED SKIN EDGES OF MINIMUM-TENSION WOUNDS FROM CLEAN SURGICAL INCISIONS AND SIMPLE, THOROUGHLY CLEANSED, TRAUMA-INDUCED LACERATIONS. HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE MAY BE USED IN CONJUNCTION WITH BUT NOT IN PLACE OF DERMAL SUTURES. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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