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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameMODELS 1S & 1P
Classification Nameintraocular lens
Generic Nameiris fixation iol
Regulation Number886.3600
PMA NumberP800049
Date Received07/17/1980
Decision Date03/31/1983
Withdrawal Date 12/23/2004
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 83M-0122
Notice Date 04/26/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 S004 S005 S006 S007 S008