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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 NumberS002
Date Received05/29/2002
Decision Date06/28/2002
Product Code
MPN[ Registered Establishments with MPN ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Packaging change from a 5 and 20 unit dose configuration to a new 12 and 24 unit dose configuration. The packaging changes will make greater use of the space within the packaging and allow more units to be shipped in the same or slightly increased volume packaging.
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