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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 NameMODIFIED J & C LOOP MODEL PA36
Classification Nameintraocular lens
Generic Namemodified j-loop posterior chamber iol
Regulation Number886.3600
ApplicantOPTRONICS, INC.
PMA NumberP880072
Supplement NumberS026
Date Received05/16/1995
Decision Date07/24/1995
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for models gs55a-ouv & gs55b-ouv ultraviolet-absorbing posterior chamber iols as tier a modifications of model pa90e-2uv and for implantation in the capsular bag only.
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