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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
4290 east brickell st, bldg a
ontario, CA 91761
PMA NumberP970034
Supplement NumberS004
Date Received02/14/2000
Decision Date04/28/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for allergan surgical to distribute the models rs-50b, rs-55b, rs-60b, rs-65, sp-60a, and sp-65a2 ultraviolet-absorbing posterior chamber intraocular lenses as allergan's duralens models 52, 53, 54, 59, 60, and 65t, respectively.