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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
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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