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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 (PURIFIED PERFLUORO-N-OCTANE LIQUID)
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantAlcon Laboratories
6201 S. Fwy., R3-48
Fort Worth, TX 76134
PMA NumberP950018
Supplement NumberS001
Date Received10/17/1996
Decision Date12/11/1996
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 MODIFICATION OF THE STABILITY PROTOCOL TO INCREASE THE ACCEPTANCE CRITERIA LIMIT FOR UV/VIS ABSORBANCE ON ACCELERATED AGIN (45 DEGREES C) SAMPLES FROM <0.2 TO <0.4 ABSORBANCE UNITS CM-1 AT 220NM
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