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 | CELLUGEL OVD |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | ALCON LABORATORIES6201 South Freewayfort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-23 |
| Decision Date | 2022-09-15 |
| PMA | P990023 |
| Supplement | S017 |
| Product Code | LZP |
| 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 fort Worth, TX 76134 PMA NumberP990023 Supplement NumberS017 Date Received08/23/2022 Decision Date09/15/2022 Product Code LZP Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change To The Pouch Seal Integrity Test Method For The Testing Of The CELLUGEL OVD Pouch |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990023 | Original Filing | |
| S018 | 2022-08-24 | 30-day Notice |
| S017 | 2022-08-23 | 30-day Notice |
| S016 | 2016-06-17 | Normal 180 Day Track |
| S015 | 2016-04-28 | Real-time Process |
| S014 | 2016-04-25 | 30-day Notice |
| S013 | 2015-04-23 | Normal 180 Day Track |
| S012 | 2014-01-31 | 30-day Notice |
| S011 | 2011-04-19 | 30-day Notice |
| S010 | 2010-10-15 | 30-day Notice |
| S009 | 2010-05-24 | 30-day Notice |
| S008 | 2009-09-15 | 30-day Notice |
| S007 | 2009-08-04 | 30-day Notice |
| S006 | 2008-11-24 | 30-day Notice |
| S005 | 2008-10-31 | 30-day Notice |
| S004 | 2008-04-08 | 30-day Notice |
| S003 | 2004-05-14 | Special (immediate Track) |
| S002 | 2003-10-24 | Special (immediate Track) |
| S001 | 2000-04-24 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00380651838109 | P990023 | 000 |