Sterility release be based on review of documentation of the ethylene oxide sterilization cycle and testing of the biological indicators and that external sterility testing of biolon syringe surfaces be discontinued.
| Device | BIOLON 1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Amring Pharmaceuticals |
| Date Received | 2000-04-25 |
| Decision Date | 2000-05-19 |
| PMA | P960011 |
| 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 | Amring Pharmaceuticals 1235 Westlakes Drive suite 205 berwyn, PA 19312 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960011 | | Original Filing |
| S034 |
2022-09-08 |
30-day Notice |
| S033 | | |
| S032 |
2019-05-07 |
Real-time Process |
| S031 |
2019-04-04 |
30-day Notice |
| S030 |
2018-03-30 |
30-day Notice |
| S029 |
2018-02-12 |
Special (immediate Track) |
| S028 |
2017-12-07 |
30-day Notice |
| S027 |
2017-12-06 |
30-day Notice |
| S026 |
2014-07-15 |
30-day Notice |
| S025 |
2014-04-28 |
30-day Notice |
| S024 |
2013-11-13 |
30-day Notice |
| S023 |
2013-05-08 |
30-day Notice |
| S022 |
2013-01-15 |
30-day Notice |
| S021 |
2012-03-05 |
30-day Notice |
| S020 |
2011-12-29 |
30-day Notice |
| S019 |
2011-03-02 |
30-day Notice |
| S018 |
2011-02-10 |
Special (immediate Track) |
| S017 |
2009-12-18 |
135 Review Track For 30-day Notice |
| S016 |
2009-12-07 |
30-day Notice |
| S015 |
2009-12-07 |
30-day Notice |
| S014 |
2009-11-09 |
30-day Notice |
| S013 |
2008-01-15 |
30-day Notice |
| S012 |
2006-11-01 |
Normal 180 Day Track No User Fee |
| S011 |
2006-09-18 |
Real-time Process |
| S010 |
2005-05-11 |
Normal 180 Day Track No User Fee |
| S009 |
2004-07-09 |
Normal 180 Day Track |
| S008 |
2002-03-18 |
Normal 180 Day Track |
| S007 |
2001-08-08 |
Normal 180 Day Track |
| S006 |
2000-09-27 |
135 Review Track For 30-day Notice |
| S005 |
2000-04-25 |
30-day Notice |
| S004 |
2000-04-11 |
Normal 180 Day Track |
| S003 |
1999-08-03 |
30-day Notice |
| S002 |
1999-03-29 |
Normal 180 Day Track |
| S001 |
1998-08-31 |
Normal 180 Day Track |
NIH GUDID Devices