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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameINDERMIL(TM) TISSUE ADHESIVE
Classification Nametissue adhesive for the topical approximation of skin
Generic Nametissue adhesive
Regulation Number878.4010
ApplicantCOVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
PMA NumberP010002
Date Received02/01/2001
Decision Date05/22/2002
Reclassified Date 05/05/2008
Product Code
MPN[ Registered Establishments with MPN ]
Docket Number 03M-0040
Notice Date 02/05/2003
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 
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