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.
| Device | ORCOLON (R) (POLYACRYLAMIDE) |
| Generic Name | Aid, Surgical, Viscoelastic |
| Applicant | OPTICAL RADIATION CORP. |
| Date Received | 1991-06-12 |
| Decision Date | 1991-07-31 |
| PMA | P900010 |
| Supplement | S002 |
| Product Code | LZP |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPTICAL RADIATION CORP. 1300 Optical Dr. azusa, CA 91702 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900010 | Original Filing | |
| S002 | 1991-06-12 | Normal 180 Day Track |
| S001 | 1991-05-14 | Normal 180 Day Track |