|
Device | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
Applicant | LUMENIS, INC. 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 |
PMA Number | P940011 |
Supplement Number | S002 |
Date Received | 03/25/1998 |
Decision Date | 12/23/1998 |
Withdrawal Date
|
01/14/2014 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). |