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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 NameSTAAR SURGICAL COLLAMER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameuv-absorbing posterior chamber iol
Regulation Number886.3600
ApplicantSTAAR SURGICAL CO.
PMA NumberP990013
Supplement NumberS008
Date Received02/22/2007
Decision Date03/22/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of the optoform lathe to the manufacturing facility of staar in monrovia, california.
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