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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 lenses (iol)21 cfr 886.3600/class iii
Regulation Number886.3600
PMA NumberP930014
Supplement NumberS069
Date Received08/09/2013
Decision Date04/28/2014
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for three alternate polypropylene materials, basell pd702, exxon achieve 1605, and exxon pp1105e1, for intraocular lens (iol) device primary packaging.