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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.
 
DeviceMICRO YAG ND:YAG LASER SYSTEM
Classification Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Generic Namelaser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Applicant
SORIN GROUP USA INC.
14401 west 65th way
arvada, CO 80004
PMA NumberP850063
Date Received09/03/1985
Decision Date01/31/1986
Withdrawal Date 05/25/2011
Product Code
LOI
Docket Number 86M-0107
Notice Date 05/30/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 
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