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.
The 30-day notice requested introduction of a manufacturing process change to use an alternate sterilization chamber (chamber #1) at griffith microscience, the same sterilization contractor approved in the original pma. Griffith is upgrading the chamber that was previously used. The proposed cycle is nearly identical to the currently-approved cycle for chamber #8, both chambers will use the computer-controlled process; the primary differences are that the chamber is smaller and an additional air wash with vacuum hold have beed added after the gas-dwell phase.
| Device | UV-PMMA PCL'S |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | AAREN SCIENTIFIC |
| Date Received | 1999-03-23 |
| Decision Date | 1999-04-16 |
| PMA | P970034 |
| Supplement | S003 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AAREN SCIENTIFIC 4290 East Brickell St, Bldg A ontario, CA 91761 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970034 | Original Filing | |
| S014 | 2009-10-28 | 135 Review Track For 30-day Notice |
| S013 | ||
| S012 | 2008-08-13 | 30-day Notice |
| S011 | 2008-08-13 | 30-day Notice |
| S010 | 2007-12-20 | 135 Review Track For 30-day Notice |
| S009 | 2001-04-19 | Normal 180 Day Track |
| S008 | 2001-03-26 | Normal 180 Day Track |
| S007 | 2000-07-06 | Normal 180 Day Track |
| S006 | 2000-04-19 | Normal 180 Day Track |
| S005 | 2000-02-14 | Normal 180 Day Track |
| S004 | 2000-02-14 | Panel Track |
| S003 | 1999-03-23 | 30-day Notice |
| S002 | 1998-12-21 | Normal 180 Day Track |
| S001 | 1998-10-22 | 30-day Notice |