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 a manufacturing site located at lifecore biomedical, llc, 1245 lakeview drive chaska, minnesota to be used for post-sterilization final packaging,warehousing, and distribution activities.
| Device | HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD) (3% SODIUM HYALURONATE), MODEL VT585 |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2016-11-14 |
| Decision Date | 2017-10-31 |
| PMA | P110007 |
| Supplement | S009 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |