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.
Your supplement requested approval for nine (9) changes to your routine ethylene oxide (eo) sterilization process, including:1. The sterilization equipment used in your routine eo sterilization process2. The implementation of a unified set of eo sterilization process parameters for your us marketed products3. The lower control limit for eo gas used in your routine eo sterilization process4. The method for monitoring eo gas concentration5. The frequency of eo sterilant residuals testing 6. The process challenge device (pcd) used during routine eo sterilization cycles and validation activities7. The number of pcds used during routine eo sterilization cycles and validation activities8. The approach used for validation/re-validation activities9. The re-validation cycle
| Device | iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System |
| Generic Name | Intraocular Lens |
| Applicant | HOYA SURGICAL OPTICS, INC. |
| Date Received | 2021-10-04 |
| Decision Date | 2021-12-28 |
| PMA | P080004 |
| Supplement | S043 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOYA SURGICAL OPTICS, INC. 14768 Pipeline Avenue chino Hills, CA 91709 |
| 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 |