RESURE SEALANT

Ophthalmic Sealant

FDA Premarket Approval P130004 S005

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

Critical supplier location change- additional facility for jenkem.

• Device: RESURE SEALANT
• Classification Name: Ophthalmic Sealant
• Generic Name: Ophthalmic Sealant
• Applicant: OCULAR THERAPEUTICS, INC.
• Date Received: 2014-09-09
• Decision Date: 2014-10-10
• PMA: P130004
• Supplement: S005
• Product Code: PFZ
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: OCULAR THERAPEUTICS, INC. 36 Crosby Dr Suite 101 bedford, MA 01730

Supplemental Filings

Supplement Number	Date	Supplement Type
P130004		Original 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
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 ID	PMA	Supp
00867968000011	P130004	000
00867968000004	P130004	000