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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DeviceVISIAN ICL (IMPLANTABLE COLLAMER LENS)
Classification Namelens, intraocular, phakic
Generic Namelens, intraocular, phakic
Applicant
STAAR SURGICAL CO.
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Date Received05/08/2003
Decision Date12/22/2005
Product Code
MTA
Docket Number 06M-0340
Notice Date 08/25/2006
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the visian icl (implantable collamer lens) models micl12. 1, micl12. 6, micl13. 2 and micl13. 7. The device is indicated for adults 21-45 years of age: 1) to correct myopia ranging from -3. 0 diopters to <=-15. 0 diopters with less than or equal to 2. 5 diopters of astigmatism at the spectacle plane; 2) to reduce myopia ranging from greater than -15. 0 diopters to -20. 0 diopters with less than or equal to 2. 5 diopters of astigmatism at the spectacle plane; and 3) with an anterior chamber depth (acd) 3. 00 mm or greater, and a stable refractive history within 0. 5 diopter for 1 year prior to implantation.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S014 S015 S016 S017 S018 S019 S020 S023 
S025 S026 S027 S028 S029 
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