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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.
 
DeviceCOLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE AND FIBRILLAR FORM
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS021
Date Received04/11/2003
Decision Date05/05/2003
Product Code LMF 
Advisory Committee General & Plastic Surgery
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  
CHANGES EFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL SPACE IN THE SAME FACILITY FOR THE ENZYME TREATMENT PROCESS USING THE SAME DEDICATED EQUIPMENT, 2) EQUIPPING THE ALKALI TREATMENT PROCESSING VESSELS WITH A DEDICATED TEMPERATURE PROBE AND CHART RECORDER TO CONTINUOUSLY MONITOR AND RECORD PRODUCT IN THE VESSELS DURING PROCESSING, 3) USE OF AN ADDITIONAL MANUFACTURING AREA, AND 4) USING A MICROWAVE MOISTURE ANALYZER, INSTEAD OF A DRY HEAT OVEN, FOR DRYING THE WEIGHTED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
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