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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTAAR SURGICAL IMPLANTABLE COLLAMER LENSES
Generic Namelens, intraocular, phakic
Applicant
STAAR Surgical Company
1911 walker ave.
monrovia, CA 91016
PMA NumberP030016
Supplement NumberS005
Date Received03/28/2008
Decision Date04/24/2008
Product Code MTA 
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
NEW HAPTIC THICKNESS MEASUREMENT MODIFICATION TO THE LATHING PROCESS FOR ALL COLLAMER LENSES MANUFACTURED AT THE NIDAU, SWITZERLAND MANUFACTURING FACILITY.
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