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. |
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Device | ReSure Sealant |
Generic Name | Ophthalmic Sealant |
Applicant | OCULAR THERAPEUTIX, INC. 36 CROSBY DR SUITE 101 BEDFORD, MA 01730 |
PMA Number | P130004 |
Supplement Number | S011 |
Date Received | 06/10/2021 |
Decision Date | 11/02/2021 |
Product Code |
PFZ |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
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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