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 the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer patients for whom surgery and radiotherapy are not indicated.
| Device | 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. |
| Date Received | 1997-02-11 |
| Decision Date | 1998-01-09 |
| PMA | P940012 |
| Supplement | S001 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | AMERICAN MEDICAL SYSTEMS, INC. 10700 Bren Road West minnetonka, MN 55343 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940012 | Original Filing | |
| S002 | 1998-03-24 | Normal 180 Day Track |
| S001 | 1997-02-11 | Normal 180 Day Track |