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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 NumberS007
Date Received03/21/1996
Decision Date04/04/1997
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to revise the directions for use insert to recommend an add'l insertion instrument, the microstaar(tm) injection system (models msi-td and msi-pd).
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