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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.
 
DeviceResure Sealant
Generic NameOphthalmic Sealant
ApplicantOCULAR THERAPEUTIX, INC.
36 CROSBY DR SUITE 101
BEDFORD, MA 01730
PMA NumberP130004
Supplement NumberS010
Date Received12/02/2020
Decision Date12/17/2020
Product Code PFZ 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
to modify the test method for the ReSure Sealant Hydrogel and Dropper Bottle Performance
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