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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINDERMIL 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
Supplement NumberS003
Date Received12/13/2002
Decision Date01/31/2003
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of a patient instruction sheet to the approved labeling.
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