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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.
 
DeviceNEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
Generic NameLaser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
ApplicantCOHERENT MEDICAL DIVISION
3270 WEST BAYSHORE RD.
P.O. BOX 10122
PALO ALTO, CA 94303
PMA NumberP830054
Date Received06/03/1983
Decision Date07/02/1984
Product Code LOI 
Docket Number 84M-0244
Notice Date 07/30/1984
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Supplements:  S001 S002 S003 S005 S006 S009 S010 S011 S012 S013 S015 
S016 S017 S018 S019 S020 S021 S022 
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