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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceRESURE SEALANT
Generic NameOphthalmic Sealant
ApplicantOCULAR THERAPEUTIX, INC.
36 CROSBY DR SUITE 101
BEDFORD, MA 01730
PMA NumberP130004
Date Received02/01/2013
Decision Date01/08/2014
Product Code PFZ 
Docket Number 14M-0069
Notice Date 01/15/2014
Advisory Committee Ophthalmic
Clinical TrialsNCT01498224
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE RESURE® SEALANT. THIS DEVICE IS INDICATED FOR INTRAOPERATIVE MANAGEMENT OF CLEAR CORNEAL INCISIONS (UP TO 3.5MM) WITH A DEMONSTRATED WOUND LEAK FOR WHICH A TEMPORARY DRY SURFACE CAN BE ACHIEVED, IN ORDER TO PREVENT POSTOPERATIVE FLUID EGRESS FROM SUCH INCISIONS FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) PLACEMENT IN ADULTS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S004 S005 S007 S008 S009 S010 S011 
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