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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.
 
DeviceMEL 80 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP060004
Supplement NumberS002
Date Received01/18/2008
Decision Date02/14/2008
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE REGARDING AN ALTERNATE LASER SOURCE.
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