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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTECHNOLAS 217A EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
TECHNOLAS PERFECT VISION GMBH
messerschmittstr 1 + 3
munchen 80992
PMA NumberP990027
Supplement NumberS005
Date Received01/31/2002
Decision Date03/13/2002
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT BAUSCH & LOMB TECHNOLAS GMBH, FELDKIRCHEN, GERMANY.
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