PMA P050013
- Device
- HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
- Applicant
- Tissue Seal, LLC
- PMA number
- P050013
- Product code
- MPN
- Decision date
- 2007-02-16
- Classification
- General, Plastic Surgery
- Generic name
- Tissue adhesive for the topical approximation of skin
- 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.
Current openFDA PMA Record#
- Device
- HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE
- Applicant
- Tissue Seal, LLC
- PMA number
- P050013
- Product code
- MPN
- Generic name
- Tissue adhesive for the topical approximation of skin
- Decision date
- 2007-02-16
- Decision code
- APRL
- Date received
- 2005-03-25
- 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.