ReSure Sealant

FDA Premarket Approval P130004 S011

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.

Pre-market Approval Supplement Details

Approval for updates to the labeling to include the findings of the post-approval study (pas) designated as the retrospective analysis study for endophthalmitis

DeviceReSure Sealant
Generic NameOphthalmic Sealant
Date Received2021-06-10
Decision Date2021-11-02
Product CodePFZ 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address OCULAR THERAPEUTIX, INC. 36 Crosby Dr Suite 101 bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P130004Original Filing
S011 2021-06-10 Normal 180 Day Track No User Fee
S010 2020-12-02 30-day Notice
S009 2020-06-18 30-day Notice
S008 2019-12-11 Normal 180 Day Track No User Fee
S007 2019-06-27 30-day Notice
S005 2014-09-09 30-day Notice
S004 2014-02-25 30-day Notice
S002 2014-02-07 Normal 180 Day Track No User Fee
S001 2014-02-07 Normal 180 Day Track No User Fee


Device IDPMASupp
00867968000011 P130004 000
00867968000004 P130004 000

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