Atlas FDA

INDERMIL(TM) TISSUE ADHESIVE

FDA premarket approval P010002 · decided 2002-05-22

Approval details

PMA number
P010002
Trade name
INDERMIL(TM) TISSUE ADHESIVE
Generic name
Tissue adhesive for the topical approximation of skin
Applicant
Covidien Lp, Formerly Registered AS United States
Date received
2001-02-01
Decision date
2002-05-22
Days to decision
475 days
Decision code
APRL
Product code
MPN
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Norwalk, CT
Statement
APPROVAL FOR THE INDERMIL TISSUE ADHESIVE. THE DEVICE IS INDICATED FOR THE CLOSURE OF TOPICAL SKIN INCISIONS INCLUDING LAPAROSCOPIC INCISIONS, AND TRAUMA-INDUCED LACERATIONS IN AREAS OF LOW SKIN TENSION THAT ARE SIMPLE, THOROUGHLY-CLEANSED, AND HAVE EASILY APPROXIMATED SKIN EDGES. INDERMIL MAY BE USED IN CONJUNCTION WITH, BUT NOT IN PLACE OF, DEEP DERMAL STITCHES.

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510(k) clearances by this applicant

RecordFirmDate
SILS CLINCHER, SILS DISSECTOR, SILS GRASPER, SILS L-HOOK, SILS SHEARS (K091869)Covidien Lp, Formerly Registered AS United States2009-09-01
ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE (K091900)Covidien Lp, Formerly Registered AS United States2009-07-16
AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS (K083519)Covidien Lp, Formerly Registered AS United States2009-04-10
SILS STITCH ENDOSCOPIC SUTURING DEVICE (K090419)Covidien Lp, Formerly Registered AS United States2009-03-09
SILS PORT, MODELS SILSPT5, SILSPT12 (K082619)Covidien Lp, Formerly Registered AS United States2008-11-07
MODIFIED ENDO STICH (K082659)Covidien Lp, Formerly Registered AS United States2008-09-19
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR (K081169)Covidien Lp, Formerly Registered AS United States2008-05-23