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 in patients for whom surgery and radiotherapy are not indicated.
| Device | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
| Applicant | LUMENIS, INC. |
| Date Received | 1997-02-14 |
| Decision Date | 1998-01-09 |
| PMA | P940011 |
| 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 | LUMENIS, INC. 3959 West 1820 South salt Lake City, UT 84104 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940011 | Original Filing | |
| S003 | 1998-07-10 | Normal 180 Day Track |
| S002 | 1998-03-25 | Normal 180 Day Track |
| S001 | 1997-02-14 | Normal 180 Day Track |