PMA P940012S001

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: 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 patients for whom surgery and radiotherapy are not indicated.

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: S001
Decision date: 1998-01-09
Decision code: APPR
Date received: 1997-02-11
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 patients for whom surgery and radiotherapy are not indicated.