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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.
 
DeviceSTAAR SURGICAL COLLAMER ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
STARR SURGICAL CO.
1911 walker ave.
monrovia, CA 91016
PMA NumberP990013
Supplement NumberS022
Date Received07/23/2008
Decision Date09/10/2008
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding in house limulus amebocyte lysate testing.
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