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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.
 
DeviceVITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantAir Products & Chemicals, Inc.
7201 Hamilton Blvd.
Allentown, PA 18951
PMA NumberP910068
Supplement NumberS001
Date Received04/26/1999
Decision Date04/04/2001
Withdrawal Date06/27/2003
Product Code LWL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR 1) MANUFACTURING SITE CHANGE: THE NEW SITE FOR MANUFACTURING THE BULK MEDICAL GRADE PERFLUOROPERHYDROPHENANTHRENE (APF-215M) WILL BE AT FLUOROMED, L.P. (FMLP), ROUND ROCK, TEXAS 78664; 2) MANUFACTURING CHANGE: APF-215M WILL BE MANUFACTURED FROM PERFLUOROPERHYDROPHENANTHRENE RAW MATERIAL INSTEAD OF FROM PHENANTHRENE RAW MATERIAL; AND 3) APF-215M SPECIFICATION CHANGE REGARDING TESTING PARAMETER FOR LOWER BOILING COMPONENTS.
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