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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.
 
DeviceUV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStaar Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP880091
Supplement NumberS010
Date Received03/26/1997
Decision Date06/30/1997
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR LENS MODEL AA-4207VF. THE DEVICE IS TO BE PLACED IN THE CAPSULAR BAG OF THE EYE AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PERSONS 60 YEARS OF AGE OR OLDER IN WHOM THE CATARACTOUS LENS HAS BEEN REMOVED BY PHACOEMULSIFICATION OR EXTRACAPSULAR CATARACT EXTRACTION.
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