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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 NumberS002
Date Received05/29/2002
Decision Date06/28/2002
Reclassified Date 05/05/2008
Product Code MPN 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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