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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePOSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAAREN SCIENTIFIC
4290 EAST BRICKELL ST, BLDG A
ONTARIO, CA 91761
PMA NumberP970034
Supplement NumberS004
Date Received02/14/2000
Decision Date04/28/2000
Withdrawal Date 08/20/2014
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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