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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 ABSORBABLE COLLAGEN WOUND DRESSING
Classification Namematerial, dressing, surgical, polylactic acid
Generic Namematerial, dressing, surgical, polylactic acid
Applicant
COLLA-TEC, INC.
p.o. box 688
plainsboro, NJ 08536
PMA NumberP840062
Supplement NumberS017
Date Received03/17/2008
Decision Date04/15/2008
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF AN ALTERNATE SUPPLIER OF BOVINE DEEP FLEXOR TENDON.
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