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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 NumberS011
Date Received06/10/2021
Decision Date11/02/2021
Withdrawal Date10/01/2025
Product Code PFZ 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the labeling to include the findings of the Post-Approval Study (PAS) designated as the Retrospective Analysis Study for Endophthalmitis.
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