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 the change of the vial material from glass to plastic for the memory lens(r) iol.
| Device | MEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL) |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | IOLTECH, S.A. |
| Date Received | 2000-09-18 |
| Decision Date | 2001-03-16 |
| PMA | P960036 |
| Supplement | S004 |
| Product Code | HQL |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |