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 modification of the stability specifications for sorbic acid concentration from a range of 0. 80 mg/ml - 1. 20 mg/ml to 0. 70 mg/ml - 1. 20 mg/ml
| Device | SORBIC ACID PRESERVED SALINE SOL.PH CHANGE |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | OPTOPICS LABORATORIES CORP. |
| Date Received | 1995-08-08 |
| Decision Date | 1995-09-20 |
| PMA | P870007 |
| Supplement | S009 |
| 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 |