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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 NameONE PIECE POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP840039
Supplement NumberS049
Date Received12/19/1995
Decision Date06/05/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the power range for your one-piece posterior chamber iols form (+4. 0 d) - (+34 d) to (-18. 0 d) - (+45 d).
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