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 | BOSTON LENS(R) CLEANER |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | POLYMER TECHNOLOGY CORP. |
| Date Received | 1994-07-22 |
| Decision Date | 1994-08-15 |
| PMA | P820069 |
| Supplement | S013 |
| Product Code | LPN |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | POLYMER TECHNOLOGY CORP. 100 Research Dr. wilmington, MA 01887 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P820069 | Original Filing | |
| S013 | 1994-07-22 | Normal 180 Day Track |
| S012 | 1989-10-17 | Normal 180 Day Track |
| S011 | 1988-01-25 | Normal 180 Day Track |
| S010 | 1987-09-17 | 30-Day Supplement |
| S009 | ||
| S008 | 1984-08-16 | |
| S007 | 1984-07-10 | |
| S006 | 1984-04-23 | |
| S005 | 1984-03-27 | |
| S004 | 1984-02-15 | |
| S003 | 1984-02-07 | |
| S002 | 1984-02-07 | |
| S001 | 1983-12-22 |