This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the hoya ispheric model ya-60bb intraocular lens. The device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
| Device | HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | HOYA SURGICAL OPTICS, INC. |
| Date Received | 2008-01-31 |
| Decision Date | 2008-09-26 |
| Notice Date | 2008-10-07 |
| PMA | P080004 |
| Supplement | S |
| Product Code | HQL |
| Docket Number | 08M-0536 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOYA SURGICAL OPTICS, INC. 14768 Pipeline Avenue chino Hills, CA 91709 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080004 | Original Filing | |
| S043 | 2021-10-04 | Real-time Process |
| S042 | ||
| S041 | 2021-05-17 | 30-day Notice |
| S040 | 2021-04-12 | 30-day Notice |
| S039 | 2020-12-14 | 30-day Notice |
| S038 | 2020-12-14 | 30-day Notice |
| S037 | 2020-09-14 | 30-day Notice |
| S036 | ||
| S035 | ||
| S034 | 2020-03-18 | Real-time Process |
| S033 | ||
| S032 | 2020-02-12 | 30-day Notice |
| S031 | ||
| S030 | ||
| S029 | 2019-12-04 | 30-day Notice |
| S028 | ||
| S027 | 2019-11-01 | 30-day Notice |
| S026 | 2019-11-01 | 30-day Notice |
| S025 | 2019-09-04 | Real-time Process |
| S024 | 2019-07-23 | 30-day Notice |
| S023 | ||
| S022 | 2018-03-26 | 30-day Notice |
| S021 | 2018-01-05 | 30-day Notice |
| S020 | 2017-11-20 | 30-day Notice |
| S019 | 2017-11-08 | 135 Review Track For 30-day Notice |
| S018 | 2017-10-02 | 30-day Notice |
| S017 | 2017-04-10 | 135 Review Track For 30-day Notice |
| S016 | 2016-12-28 | Real-time Process |
| S015 | 2014-03-19 | Real-time Process |
| S014 | 2013-08-30 | 30-day Notice |
| S013 | 2012-12-19 | Real-time Process |
| S012 | 2012-05-29 | Real-time Process |
| S011 | 2012-05-18 | Normal 180 Day Track |
| S010 | 2011-12-23 | 30-day Notice |
| S009 | 2011-09-29 | 30-day Notice |
| S008 | 2011-07-18 | 135 Review Track For 30-day Notice |
| S007 | 2011-04-27 | Real-time Process |
| S006 | 2011-03-08 | 30-day Notice |
| S005 | 2010-02-23 | 135 Review Track For 30-day Notice |
| S004 | 2010-01-21 | Normal 180 Day Track |
| S003 | ||
| S002 | 2009-02-24 | 135 Review Track For 30-day Notice |
| S001 | 2009-01-14 | Normal 180 Day Track |