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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceUV-ELASTIC POSTERIOR CHAMBER IOL FOR LENS MODEL AA-4207VFHAMBER IOL'S
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
STARR SURGICAL CO.
1911 walker ave.
monrovia, CA 91016
PMA NumberP880091
Supplement NumberS010
Date Received03/26/1997
Decision Date06/30/1997
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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