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 relocation of the griffith microscience sterilization site to 27 park rd. , glen falls, ny.
| Device | SORBIC ACID PRESERVED LENS LUBRICANT |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | PACO PHARMACEUTICAL SERVICES, INC. |
| Date Received | 1997-05-01 |
| Decision Date | 1997-07-02 |
| PMA | P850075 |
| Supplement | S009 |
| 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 | PACO PHARMACEUTICAL SERVICES, INC. 1200 Paco Way building 19 lakewood, NJ 08701 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850075 | Original Filing | |
| S009 | 1997-05-01 | Normal 180 Day Track |
| S008 | 1990-06-20 | Normal 180 Day Track |
| S007 | 1989-09-11 | Normal 180 Day Track |
| S006 | 1989-09-06 | Normal 180 Day Track |
| S005 | 1988-05-13 | Special (immediate Track) |
| S004 | 1988-04-19 | Normal 180 Day Track |
| S003 | 1987-08-05 | Normal 180 Day Track |
| S002 | 1987-05-11 | Normal 180 Day Track |
| S001 | 1987-01-16 | Normal 180 Day Track |