HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
FDA premarket approval P050013 · decided 2007-02-16
Approval details
- PMA number
- P050013
- Trade name
- HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
- Generic name
- Tissue adhesive for the topical approximation of skin
- Applicant
- Tissue Seal, LLC
- Date received
- 2005-03-25
- Decision date
- 2007-02-16
- Days to decision
- 693 days
- Decision code
- APRL
- Product code
- MPN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Ann Arbor, MI
- 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.
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