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.
Approval for an alternate sterilization process using 100% ethylene oxide, an alterante microbiological monitoring system and one resterilization in the event of an "aborted cycle. "
| Device | 3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ALCONRESEARCH,LTD. |
| Date Received | 1996-08-08 |
| Decision Date | 1998-09-04 |
| PMA | P830040 |
| Supplement | S026 |
| Product Code | HQL |
| 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 | ALCONRESEARCH,LTD. 6201 South Freeway fort Worth,, TX 76134 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P830040 | Original Filing | |
| S026 | 1996-08-08 | Normal 180 Day Track |
| S025 | 1995-08-09 | Normal 180 Day Track |
| S024 | 1995-01-31 | Normal 180 Day Track |
| S023 | 1991-10-01 | Normal 180 Day Track |
| S022 | 1991-08-22 | Normal 180 Day Track |
| S021 | 1991-07-01 | Normal 180 Day Track |
| S020 | 1991-05-08 | Normal 180 Day Track |
| S019 | ||
| S018 | 1991-03-12 | Normal 180 Day Track |
| S017 | 1991-02-14 | Normal 180 Day Track |
| S016 | ||
| S015 | 1990-07-05 | Normal 180 Day Track |
| S014 | 1990-04-24 | Normal 180 Day Track |
| S013 | 1989-12-29 | Normal 180 Day Track |
| S012 | ||
| S011 | 1988-12-23 | Normal 180 Day Track |
| S010 | 1988-12-19 | Normal 180 Day Track |
| S009 | 1988-12-14 | Normal 180 Day Track |
| S008 | 1988-11-14 | Panel Track |
| S007 | ||
| S006 | ||
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | 1985-04-10 | |
| S001 | 1984-11-09 |