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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 NameELASTIC UVA PC IOL
Classification Nameintraocular lens
Generic Nameiol's
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP880091
Supplement NumberS017
Date Received07/30/1999
Decision Date09/02/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested that staar surgical company be permitted to implement a gentinge castle autoclave to sterilize products during the scheduled or unscheduled shutdown of the primary autoclave manufactured by kuhlman technologies, inc.
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