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 | Perfluoron™ |
| Generic Name | Fluid, Intraocular |
| Applicant | ALCON LABORATORIES6201 South Freeway R3-48fort Worth, TX 76134 PMA NumberP950018 Supplement NumberS021 Date Received07/18/2022 Decision Date08/12/2022 Product Code LWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-18 |
| Decision Date | 2022-08-12 |
| PMA | P950018 |
| Supplement | S021 |
| Product Code | LWL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ALCON LABORATORIES 6201 South Freeway R3-48 fort Worth, TX 76134 PMA NumberP950018 Supplement NumberS021 Date Received07/18/2022 Decision Date08/12/2022 Product Code LWL Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement adding An Alternate Supplier Of Potassium Hydroxide |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950018 | Original Filing | |
| S021 | 2022-07-18 | 30-day Notice |
| S020 | 2021-10-26 | 30-day Notice |
| S019 | 2020-06-29 | 30-day Notice |
| S018 | 2015-03-26 | 30-day Notice |
| S017 | ||
| S016 | 2012-11-08 | Normal 180 Day Track |
| S015 | 2012-01-30 | Real-time Process |
| S014 | 2010-11-22 | 30-day Notice |
| S013 | 2010-03-05 | 30-day Notice |
| S012 | ||
| S011 | 2009-07-14 | Normal 180 Day Track |
| S010 | 2008-04-15 | Normal 180 Day Track No User Fee |
| S009 | 2003-02-14 | Real-time Process |
| S008 | 2001-12-26 | Real-time Process |
| S007 | 2001-07-13 | 30-day Notice |
| S006 | 2001-04-24 | 30-day Notice |
| S005 | 2001-02-26 | 30-day Notice |
| S004 | 2000-02-17 | Normal 180 Day Track |
| S003 | 1999-03-26 | Normal 180 Day Track |
| S002 | 1999-02-11 | Real-time Process |
| S001 | 1996-10-17 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00380659001642 | P950018 | 000 |
| 10380659001632 | P950018 | 000 |