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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 NameMODEL 304 (ULTRA C-LOOP)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantIOPTEX, INC.
PMA NumberP860059
Supplement NumberS009
Date Received08/03/1988
Decision Date01/26/1989
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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