INDERMIL TISSUE ADHESIVE

FDA premarket approval P010002/S004 · decided 2003-11-12

Approval details

PMA number

P010002

Supplement

S004

Supplement type

Real-Time Process

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

INDERMIL TISSUE ADHESIVE

Generic name

Tissue adhesive for the topical approximation of skin

Applicant

Covidien Lp, Formerly Registered AS United States

Date received

2003-05-19

Decision date

2003-11-12

Days to decision

177 days

Decision code

APPR

Product code

MPN

Advisory committee

General, Plastic Surgery

Expedited review

No

Location

Norwalk, CT

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

510(k) clearances by this applicant