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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.
 
DeviceCollaCote/ CollaTape/ CollePlug/Absorbable Collegen Wound Dressings
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS058
Date Received11/07/2016
Decision Date12/11/2016
Product Code LPG 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Clearance for an Electronic Chart Recorder (E-Chart System) for the Hull 2 and Hull 3 Lyophilizer (freeze dryer). The E-Chart system provides visualization, data acquisition, trouble shooting, and trending capabilities of the Hull 2 and 3 lyophilization process to maintenance and engineering personnel. This system is meant to supplement but not replace the current Yokogawa paper chart recorders on these lines, which collect and plot lyophilization process parameters but have no storage or information transfer capabilities.
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