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 eliminate ethylene oxide sterilization of the flip-top piercing cap attached to sealed 12 oz. And 16 oz. Containers of sterile preserved saline solution.
| Device | STERILE SALINE PRESERVED SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | AUTOMATIC LIQUID PACKAGING, INC. |
| Date Received | 1997-06-04 |
| Decision Date | 1997-07-02 |
| PMA | P850070 |
| Supplement | S010 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AUTOMATIC LIQUID PACKAGING, INC. 2200 W. Lake Shore Dr. woodstock, IL 60098 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850070 | Original Filing | |
| S010 | 1997-06-04 | Normal 180 Day Track |
| S009 | 1997-02-14 | Normal 180 Day Track |
| S008 | 1995-11-03 | Normal 180 Day Track |
| S007 | ||
| S006 | 1990-08-28 | Normal 180 Day Track |
| S005 | 1990-03-27 | Normal 180 Day Track |
| S004 | 1989-10-25 | Normal 180 Day Track |
| S003 | 1989-04-26 | Normal 180 Day Track |
| S002 | 1987-06-17 | Normal 180 Day Track |
| S001 |