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.
Approval for changes made to the directions for use (dfu) to clarify instructions for use of the finger grip.
| Device | HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICES (OVD), (3% SODIUM HYALURONATE) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2015-11-25 |
| Decision Date | 2015-12-22 |
| PMA | P110007 |
| Supplement | S007 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Johnson & Johnson Surgical Vision, Inc. 1700 E. St. Andrew Place santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110007 | Original Filing | |
| S013 | 2020-10-01 | 30-day Notice |
| S012 | 2020-04-29 | 30-day Notice |
| S011 | 2016-11-16 | 30-day Notice |
| S010 | ||
| S009 | 2016-11-14 | Normal 180 Day Track No User Fee |
| S008 | 2016-08-01 | Real-time Process |
| S007 | 2015-11-25 | Special (immediate Track) |
| S006 | 2015-02-18 | 30-day Notice |
| S005 | 2013-05-28 | 30-day Notice |
| S004 | 2013-04-01 | 30-day Notice |
| S003 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S002 | 2013-03-15 | 30-day Notice |
| S001 | 2012-09-12 | 30-day Notice |