PMA P940011S001

Device: COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Applicant: Lumenis, Inc.
PMA number: P940011
Supplement: S001
Decision date: 1998-01-09
Approval order statement: 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.

Current openFDA PMA Record#

Device: COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Applicant: Lumenis, Inc.
PMA number: P940011
Supplement: S001
Decision date: 1998-01-09
Decision code: APPR
Date received: 1997-02-14
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 treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.