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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMODEL 91-50 IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP820044
Date Received07/12/1982
Decision Date12/27/1985
Withdrawal Date 04/06/2009
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 86M-0032
Notice Date 02/14/1986
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 
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