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.
Conversion of an existing clean room space into an additional formulation room for the use in the production of the healon endocoat ovd.
| Device | AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD),(3% SODIUM HYALURONATE) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Date Received | 2013-05-28 |
| Decision Date | 2013-06-27 |
| PMA | P110007 |
| Supplement | S005 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process 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 |