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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameophthalmic sealant
Generic Nameophthalmic sealant
36 crosby dr suite 101
bedford, MA 01730
PMA NumberP130004
Date Received02/01/2013
Decision Date01/08/2014
Product Code
PFZ[ Registered Establishments with PFZ ]
Docket Number 14M-0069
Notice Date 01/15/2014
Advisory Committee Ophthalmic
Clinical Trials NCT01498224
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005