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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 SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC
Classification Namelens, intraocular, toric optics
Generic Nameiol's
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP880091
Supplement NumberS014
Date Received12/16/1997
Decision Date11/04/1998
Product Code
MJP[ Registered Establishments with MJP ]
Docket Number 98M-0998
Notice Date 12/17/1998
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
This device is indicated for improving uncorrected visual acuity, correcting aphakia and decreasing refractive cylinder resulting from corneal astigmatism in persons aged 60 and over.
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