PMA P940011S002

Device: COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Applicant: Lumenis, Inc.
PMA number: P940011
Supplement: S002
Decision date: 1998-12-23
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).

Current openFDA PMA Record#

Device: COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Applicant: Lumenis, Inc.
PMA number: P940011
Supplement: S002
Decision date: 1998-12-23
Decision code: APPR
Date received: 1998-03-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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).