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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 ELASTIC/ELASTIMIDE/ELASTIC TORIC/ASPHERIC ELASTIMIDE ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
STARR SURGICAL CO.
1911 walker ave.
monrovia, CA 91016
PMA NumberP880091
Supplement NumberS030
Date Received01/15/2008
Decision Date02/13/2009
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Installation of a new collimator on the autometronics obv-750 optical bench.
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