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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 NumberS001
Date Received05/24/2002
Decision Date06/20/2002
Reclassified Date05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
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 LABELING CHANGES TO INCLUDE AN EXTENSION TO THE LABELED DEVICE SHELF-LIFE FROM 12 MONTHS TO 24 MONTHS AND A 4-WEEK AMBIENT STORAGE CLAIM.
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