PMA P940012

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.
PMA number: P940012
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 obstrucint endobronchial nonsmall cell lung cancer (NSCLC).

Current openFDA PMA Record#

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.
PMA number: P940012
Supplement: S002
Decision date: 1998-12-23
Decision code: APPR
Date received: 1998-03-24
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 obstrucint endobronchial nonsmall cell lung cancer (NSCLC).