|
Device | RESURE SEALANT |
Generic Name | Ophthalmic Sealant |
Applicant | OCULAR THERAPEUTIX, INC. 36 CROSBY DR SUITE 101 BEDFORD, MA 01730 |
PMA Number | P130004 |
Date Received | 02/01/2013 |
Decision Date | 01/08/2014 |
Product Code |
PFZ |
Docket Number | 14M-0069 |
Notice Date | 01/15/2014 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT01498224
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE RESURE® SEALANT. THIS DEVICE IS INDICATED FOR INTRAOPERATIVE MANAGEMENT OF CLEAR CORNEAL INCISIONS (UP TO 3.5MM) WITH A DEMONSTRATED WOUND LEAK FOR WHICH A TEMPORARY DRY SURFACE CAN BE ACHIEVED, IN ORDER TO PREVENT POSTOPERATIVE FLUID EGRESS FROM SUCH INCISIONS FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) PLACEMENT IN ADULTS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S005 S007 S008 S009 S010 S011 |