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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.
 
DeviceMICRORUPTOR MR-2 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
MERIDIAN AG
bierigutstrauss 7
ch-3608
thun, be 
PMA NumberP840012
Date Received03/19/1984
Decision Date01/31/1986
Withdrawal Date 09/15/2011
Product Code
LOI
Docket Number 86M-0106
Notice Date 03/28/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S005 S006 S007 
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