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.
Addition of an alternate steam sterilizer for the terminal sterilization of the cv232 sre pre-rolled acrylic intraocular lens.
| Device | CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS |
| Classification Name | Intraocular Lens |
| Generic Name | Intraocular Lens |
| Applicant | IOLTECH, S.A. |
| Date Received | 2002-07-08 |
| Decision Date | 2002-07-26 |
| PMA | P960036 |
| Supplement | S007 |
| 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 | 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 |