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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINDERMIL TISSUE ADHESIVE
Generic NameTissue adhesive for the topical approximation of skin
Regulation Number878.4010
ApplicantCovidien Lp, Formerly Registered AS United States
150 Glover Ave.
Norwalk, CT 06856
PMA NumberP010002
Supplement NumberS003
Date Received12/13/2002
Decision Date01/31/2003
Reclassified Date05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A PATIENT INSTRUCTION SHEET TO THE APPROVED LABELING.
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