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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 NumberS001
Date Received05/24/2002
Decision Date06/20/2002
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
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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