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 an alternate closure design which utilizes a piercing cap and "flip-top" on 12 oz. And 16 oz. Preserved sline solution containers only
| Device | STERILE SALINE PRESERVED SOLUTION |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | AUTOMATIC LIQUID PACKAGING, INC. |
| Date Received | 1995-11-03 |
| Decision Date | 1996-07-10 |
| PMA | P850070 |
| Supplement | S008 |
| 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 | 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 |