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.
Alternate vendor to perform limulus amebocyte lysate (lal) testing.
| Device | ANTERIOR CHAMBER INTRAOCULAR LENS |
| Generic Name | Intraocular Lens |
| Applicant | AAREN SCIENTIFIC |
| Date Received | 2012-02-02 |
| Decision Date | 2012-03-02 |
| PMA | P010027 |
| Supplement | S004 |
| 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 |
|---|---|---|
| P010027 | Original Filing | |
| S005 | 2012-02-02 | 30-day Notice |
| S004 | 2012-02-02 | 30-day Notice |
| S003 | 2009-10-28 | 135 Review Track For 30-day Notice |
| S002 | 2008-08-13 | 30-day Notice |
| S001 | 2008-08-13 | 30-day Notice |