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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.
 
DeviceCOLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS033
Date Received08/05/2013
Decision Date04/07/2014
Product Code LPG 
Advisory Committee Dental
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) A NEW ALKALINE DETERGENT FOR USE AS A CLEANING AGENT; 2) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES; 3) SWAB AND RINSE RECOVERY FACTORS AND A VISUAL LIMIT OF DETECTION FOR MEDICAL MANUFACTURING AREA SOIL ON STAINLESS STEEL AND ALUMINUM SURFACES; 4) PROPOSED CHANGE IN EQUIPMENT DIRTY HOLD TIMES (DHTS) FOR THE DOUBLE DENSITY HEMOSTATIC DISPERSION, CROSS-LINKING PROCESS EQUIPMENT AND THE MOLD FILLING EQUIPMENT; AND5) PROPOSED INSTALLATION AND OPERATIONAL QUALIFICATION OF A NEW ULTRASONICATOR.
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