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 to market the device in a 16 fl. Oz. Container size
| Device | SORBIC ACID PRESERVED SALINE SOL.PH CHANGE |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | OPTOPICS LABORATORIES CORP. |
| Date Received | 1996-05-20 |
| Decision Date | 1996-11-13 |
| PMA | P870007 |
| Supplement | S011 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPTOPICS LABORATORIES CORP. 32 Main St., P.o. Box 210 fairton, NJ 08320-0210 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P870007 | Original Filing | |
| S011 | 1996-05-20 | Normal 180 Day Track |
| S010 | 1995-10-03 | Normal 180 Day Track |
| S009 | 1995-08-08 | Normal 180 Day Track |
| S008 | ||
| S007 | ||
| S006 | 1992-05-12 | Normal 180 Day Track |
| S005 | 1992-01-29 | Normal 180 Day Track |
| S004 | ||
| S003 | 1990-05-11 | Special (immediate Track) |
| S002 | ||
| S001 | 1988-01-27 | Normal 180 Day Track |