To modify the test method for the resure sealant hydrogel and dropper bottle performance
Device | Resure Sealant |
Generic Name | Ophthalmic Sealant |
Applicant | OCULAR THERAPEUTIX, INC. |
Date Received | 2020-12-02 |
Decision Date | 2020-12-17 |
PMA | P130004 |
Supplement | S010 |
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 THERAPEUTIX, 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