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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, COLLAPLUG, COLLATAPE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS008
Date Received04/16/2003
Decision Date05/16/2003
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  
CHANGES AFFECTING MANUFACTURING PROCESSES INCLUDING: 1) QUALIFYING ADDITIONAL MANUFACTURING ROOM, 2) MODIFYING THE TEMPERATURE MONITORING METHOD, 3) ADDITION OF A DIFFERENT AGENT FOR CLEANSING THE MANUFACTURING AREA, AND 4) MODIFYING THE METHOD FOR DRYING THE WEIGHED SAMPLES OF ALKALI TREATED COLLAGEN SLICES.
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