PMA P010002

Device: INDERMIL TISSUE ADHESIVE
Applicant: Covidien Lp, Formerly Registered AS United States
PMA number: P010002
Supplement: S004
Product code: MPN
Decision date: 2003-11-12
Classification: General, Plastic Surgery
Generic name: Tissue adhesive for the topical approximation of skin
Approval order statement: APPROVAL FOR THE ADDITION OF A CANNULA TO THE APPLICATOR AND A MICROBIAL BARRIER CLAIM TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDERMIL. TISSUE ADHESIVE AND IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC SKIN INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES. IN VITRO STUDIES HAVE ALSO SHOWN THAT INDERMIL MAY ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN THE ADHESIVE FILM REMAINS UNBROKEN. INDERMIL TISSUE ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.

Current openFDA PMA Record#

Device: INDERMIL TISSUE ADHESIVE
Applicant: Covidien Lp, Formerly Registered AS United States
PMA number: P010002
Supplement: S004
Product code: MPN
Generic name: Tissue adhesive for the topical approximation of skin
Decision date: 2003-11-12
Decision code: APPR
Date received: 2003-05-19
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE ADDITION OF A CANNULA TO THE APPLICATOR AND A MICROBIAL BARRIER CLAIM TO THE LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INDERMIL. TISSUE ADHESIVE AND IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC SKIN INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES. IN VITRO STUDIES HAVE ALSO SHOWN THAT INDERMIL MAY ACT AS A BARRIER TO MICROBIAL PENETRATION WHEN THE ADHESIVE FILM REMAINS UNBROKEN. INDERMIL TISSUE ADHESIVE MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.