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.
| Device | BIOLON® |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | Altacor Ltd.merlin House, Brunel Roadtheale RG7 4 PMA NumberP960011 Supplement NumberS034 Date Received09/08/2022 Decision Date10/03/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-08 |
| Decision Date | 2022-10-03 |
| PMA | P960011 |
| Supplement | S034 |
| 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 | Altacor Ltd. merlin House, Brunel Road theale RG7 4 PMA NumberP960011 Supplement NumberS034 Date Received09/08/2022 Decision Date10/03/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Make A Change To The Concentration Step In The Manufacturing Process |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 15060156070380 | P960011 | 001 |
| 01369918000007 | P960011 | 027 |