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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 NamePERFLUORON OCULAR ENDOTAMPONADE
Classification Namefluid, intraocular
Generic Nameliquid ultrapure perfluoro-n-octane (pfno)
Regulation Number886.4275
ApplicantALCON LABORATORIES
PMA NumberP950018
Supplement NumberS016
Date Received11/30/2012
Decision Date07/09/2013
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the adhesive resins (limonene-based resin tr7125 has replaced the current limonene-based resin tr1135, and ethylene vinyl acetate resin ul8705 has replaced the current eva resin 205w) used for the tyvek lid and validation of an air-over-steam (aos) sterilization cycle to align practices among products within the manufacturing facility.
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