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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
Device600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka, MN 55343
PMA NumberP940012
Date Received04/13/1994
Decision Date12/27/1995
Withdrawal Date 04/30/2014
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 97M-0204
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR THE 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG (OPERATING AT 532 NM) SURGICAL LASERS
Supplements: S001 S002 
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