ReSure Sealant

FDA Premarket Approval P130004 S009

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

A change to the reference dose and the delivered dose range for the routine gamma radiation process

DeviceReSure Sealant
Generic NameOphthalmic Sealant
ApplicantOCULAR THERAPEUTIX, INC.
Date Received2020-06-18
Decision Date2020-07-16
PMAP130004
SupplementS009
Product CodePFZ 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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
S006
S005 2014-09-09 30-day Notice
S004 2014-02-25 30-day Notice
S003
S002 2014-02-07 Normal 180 Day Track No User Fee
S001 2014-02-07 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00867968000011 P130004 000
00867968000004 P130004 000

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.