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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.
 
DevicePERFLUORON
Classification Namefluid, intraocular
Generic Namefluid, intraocular
Regulation Number886.4275
Applicant
ALCON LABORATORIES
6201 south freeway r3-48
fort worth, TX 76134
PMA NumberP950018
Supplement NumberS008
Date Received12/26/2001
Decision Date07/29/2002
Product Code
LWL[ Registered Establishments with LWL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ADDING BLISTER PACKAGING TO THE VIAL PRODUCT THAT IS THEN SUBJECTED TO A STEAM STERILIZATION PROCESS IN ORDER TO PROVIDE A FINISHED PRODUCT VIAL WITH A STERILE EXTERIOR. ALSO, APPROVAL OF A 10 ML VIAL FOR THE 7 ML FILL PRODUCT TO ALLOW STERILIZATION HEADSPACE.
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