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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceUV-ABSORBING SILICONE POSTERIOR CHAMBER IOLS W/TORIC OPTIC
Generic NameLENS, INTRAOCULAR, TORIC OPTICS
Regulation Number886.3600
ApplicantSTAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP880091
Supplement NumberS014
Date Received12/16/1997
Decision Date11/04/1998
Product Code MJP 
Docket Number 98M-0998
Notice Date 12/17/1998
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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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