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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.
 
Trade NameCOLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP990013
Supplement NumberS001
Date Received07/24/2000
Decision Date09/25/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new manufacturing facility at staar surgical co. , monrovia, california.
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