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 reduction of obstruction and palliation of symptoms in patients with completely or partially obstrucint endobronchial nonsmall cell lung cancer (nsclc).
| 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 | 1998-03-24 |
| Decision Date | 1998-12-23 |
| PMA | P940012 |
| Supplement | S002 |
| 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 |