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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.
 
DeviceHELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY
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 NumberS014
Date Received07/26/2007
Decision Date10/30/2007
Product Code
LPG[ Registered Establishments with LPG ]
Advisory Committee Dental
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF TWO NEW TRADE NAMES - HELITAPE AND HELIPLUG ABSORBABLE COLLAGEN WOUND DRESSING FOR DENTAL SURGERY.
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