Approval for the use of a new packaging suite and for the use of a semi-automatic provess for assembly and labeling of the biolon(tm) syringes.
| Device | BIOLON TM |
| Classification Name | Aid, Surgical, Viscoelastic |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Amring Pharmaceuticals |
| Date Received | 1999-03-29 |
| Decision Date | 1999-07-01 |
| PMA | P960011 |
| Supplement | S002 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| 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