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 | THE BOSTON TM CLEANER II |
| Generic Name | Accessories, Soft Lens Products |
| Applicant | POLYMER TECHNOLOGY CORP. |
| Date Received | 1994-07-22 |
| Decision Date | 1994-08-15 |
| PMA | P890054 |
| Supplement | S001 |
| 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 |
|---|---|---|
| P890054 | Original Filing | |
| S001 | 1994-07-22 | Normal 180 Day Track |