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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.
 
DevicePERFLUORON
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP950018
Supplement NumberS011
Date Received07/14/2009
Decision Date08/14/2013
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFIED STABILITY PROTOCOL, A CHANGE IN THE PACKAGING TO AN ALTERNATE ALUMINUM SEAL WITH A FLIP-OFF CAP, AND THE ADDITION OF A PRE-PROCESSING MODIFICATION TO SILICONIZE THE STOPPERS USED IN THE FILLING, STOPPING, AND SEALING OF PERFLUORON..
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