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 | Biomedics 55 Asphere |
| Generic Name | Lenses, Soft Contact, Extended Wear |
| Applicant | THE COOPER COMPANIES6150 Stoneridge Mall Roadsuite 370pleasanton, CA 94588 PMA NumberP890023 Supplement NumberS048 Date Received04/26/2022 Decision Date05/24/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-26 |
| Decision Date | 2022-05-24 |
| PMA | P890023 |
| Supplement | S048 |
| Product Code | LPM |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | THE COOPER COMPANIES 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588 PMA NumberP890023 Supplement NumberS048 Date Received04/26/2022 Decision Date05/24/2022 Product Code LPM Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of Biomedics 55 Asphere Lens Capability To The Low Volume Automation (LVA1) Manufacturing Line At The CooperVision, Inc. Facility In Scottsville, New York |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P890023 | Original Filing | |
| S049 | 2022-08-29 | 30-day Notice |
| S048 | 2022-04-26 | 30-day Notice |
| S047 | 2020-09-25 | 30-day Notice |
| S046 | ||
| S045 | 2020-08-24 | 30-day Notice |
| S044 | 2020-08-20 | 30-day Notice |
| S043 | 2020-08-03 | 30-day Notice |
| S042 | 2020-01-15 | 30-day Notice |
| S041 | ||
| S040 | 2019-12-03 | 30-day Notice |
| S039 | 2019-10-15 | 30-day Notice |
| S038 | 2019-08-13 | 30-day Notice |
| S037 | 2019-02-26 | 30-day Notice |
| S036 | 2019-02-08 | 30-day Notice |
| S035 | 2018-08-09 | Normal 180 Day Track No User Fee |
| S034 | 2018-06-18 | Real-time Process |
| S033 | 2018-06-15 | Real-time Process |
| S032 | 2018-04-05 | Normal 180 Day Track No User Fee |
| S031 | 2018-03-16 | 135 Review Track For 30-day Notice |
| S030 | 2018-01-16 | 135 Review Track For 30-day Notice |
| S029 | 2017-10-24 | 30-day Notice |
| S028 | 2017-08-04 | Real-time Process |
| S027 | 2017-01-30 | 30-day Notice |
| S026 | 2017-01-08 | 30-day Notice |
| S025 | 2016-04-13 | Normal 180 Day Track No User Fee |
| S024 | 2015-12-22 | 30-day Notice |
| S023 | 2015-07-02 | 30-day Notice |
| S022 | 2014-09-08 | Normal 180 Day Track No User Fee |
| S021 | 2013-11-13 | 135 Review Track For 30-day Notice |
| S020 | 2013-11-12 | 30-day Notice |
| S019 | 2013-07-22 | 30-day Notice |
| S018 | 2011-11-01 | 30-day Notice |
| S017 | 2010-04-26 | 135 Review Track For 30-day Notice |
| S016 | 2004-08-18 | Real-time Process |
| S015 | 2004-07-02 | Normal 180 Day Track No User Fee |
| S014 | 2003-12-22 | Normal 180 Day Track No User Fee |
| S013 | 2002-01-18 | Normal 180 Day Track |
| S012 | ||
| S011 | 2001-07-20 | Normal 180 Day Track |
| S010 | ||
| S009 | 1999-09-17 | Normal 180 Day Track |
| S008 | 1999-07-29 | 30-day Notice |
| S007 | 1999-04-20 | Real-time Process |
| S006 | 1996-02-13 | Normal 180 Day Track |
| S005 | 1995-10-23 | Normal 180 Day Track |
| S004 | 1995-10-02 | Normal 180 Day Track |
| S003 | 1995-09-29 | Normal 180 Day Track |
| S002 | 1993-05-24 | Normal 180 Day Track |
| S001 | 1990-10-31 | Normal 180 Day Track |