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 transfer of the processing site for 100 percent ethylene oxide (eto) sterilization of plastic containers, tips and closures used in the manufacture of sorbic acid preserved sterile saline for soft contact lenses. The eto sterilization facility is griffith microscience glen falls facility, located in glen falls, ny
| Device | SORBIC ACID PRESERVED SALINE SOL.PH CHANGE |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | OPTOPICS LABORATORIES CORP. |
| Date Received | 1995-10-03 |
| Decision Date | 1996-04-22 |
| PMA | P870007 |
| Supplement | S010 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| 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 |