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 including aeration time and the establishment of the biological indicator incubation time
| Device | 3M VISION CARE POSTERIOR CHAMBER IOL,PERSPEX CQ-UV |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | ALCONRESEARCH,LTD. |
| Date Received | 1995-08-09 |
| Decision Date | 1995-12-13 |
| PMA | P830040 |
| Supplement | S025 |
| 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 |