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.
Approval for a shelf-life extension to 18 months, a proposed protocol for additional shel-life extensions, and a new dimensional specification.
| Device | MEMORY LENS MODEL U940A UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | IOLTECH, S.A. |
| Date Received | 1999-08-23 |
| Decision Date | 2000-08-25 |
| PMA | P960036 |
| Supplement | S001 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Real-time Process |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IOLTECH, S.A. 64 Schoosett Street penbroke, MA 02359-1882 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960036 | Original Filing | |
| S007 | 2002-07-08 | 30-day Notice |
| S006 | 2002-06-06 | Real-time Process |
| S005 | 2001-12-21 | Normal 180 Day Track |
| S004 | 2000-09-18 | Normal 180 Day Track |
| S003 | 2000-08-31 | Normal 180 Day Track |
| S002 | 2000-07-17 | Normal 180 Day Track |
| S001 | 1999-08-23 | Real-time Process |