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 approval to introduce a manufacturing process change for the device. The nature of the change is to use an alternate sterilization chambera t griffith microscience, the same sterilization contractor approved in the firm's original pma. Griffith is upgrading the chamber that was previously used. Some of the parameters of the sterilization process are being changed. The changes include reduction of the minimum preconditioning time, specification of the transfer time to move the load from the preconditioning room into the sterilization chamber, use of a larger sterilization chamber, use of a computer-controlled process versus a manually-controlled process and the addition of post-ethylene oxide exposure vacuum dwell times.
| Device | UV ABSORBING-PMMA POSTERIOR CHAMBER INTRAOCULAR LENSES |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | AAREN SCIENTIFIC |
| Date Received | 1998-10-22 |
| Decision Date | 1998-11-20 |
| PMA | P970034 |
| Supplement | S001 |
| 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 |