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 an expansion of the indications for use of the subject devices to include fluorosilicone acrylate rigid gas permeable contact lenses.
| Device | SEREINE WETTING & SOAKING SOLU. (NEW PRESERVATIVE) |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | TRP COMPANY |
| Date Received | 1997-04-22 |
| Decision Date | 1997-10-15 |
| PMA | P870051 |
| Supplement | S007 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TRP COMPANY 1575 Delucci Lane #115 reno, NV 89502 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870051 | Original Filing | |
| S007 | 1997-04-22 | Normal 180 Day Track |
| S006 | 1996-06-04 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | 1991-11-19 | Normal 180 Day Track |
| S002 | ||
| S001 | 1990-07-10 | Normal 180 Day Track |