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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 NameUV-ABSORBING ELASTIC LENS(TM) AND ELASTIMIDE(TM) POSTERIOR CHAMBER IOL'S
Classification Nameintraocular lens
Generic Nameiol's
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP880091
Supplement NumberS006
Date Received12/04/1995
Decision Date07/01/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add an alternate vendor for part of your manufacturing process.
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