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 | CRYSTALENS SALINE SPRAY |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | STERICON, INC. |
| Date Received | 1987-03-18 |
| Decision Date | 1987-09-09 |
| PMA | P850065 |
| Supplement | S006 |
| 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 | STERICON, INC. 19742 Macarthur Blvd. suite 235 irvine, CA 92715 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850065 | Original Filing | |
| S013 | 1990-06-22 | Normal 180 Day Track |
| S012 | 1988-03-15 | Normal 180 Day Track |
| S011 | ||
| S010 | ||
| S009 | 1987-10-13 | Normal 180 Day Track |
| S008 | 1987-03-19 | Normal 180 Day Track |
| S007 | 1987-03-19 | Normal 180 Day Track |
| S006 | 1987-03-18 | Normal 180 Day Track |
| S005 | ||
| S004 | ||
| S003 | ||
| S002 | 1986-07-03 | Normal 180 Day Track |
| S001 |