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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
Classification Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
ApplicantCOHERENT MEDICAL DIVISION
PMA NumberP830054
Supplement NumberS009
Date Received05/28/1986
Decision Date11/07/1986
Product Code
LOI
Docket Number 86M-0486
Notice Date 12/31/1986
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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