PMA P910068

Device: VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)
Applicant: Air Products & Chemicals, Inc.
PMA number: P910068
Supplement: S001
Product code: LWL
Decision date: 2001-04-04
Generic name: Fluid, intraocular
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.

Current openFDA PMA Record#

Device: VITREON INTRAOCULAR FLUID (PERFLUOROPERHYDROPHENANTHRENE)
Applicant: Air Products & Chemicals, Inc.
PMA number: P910068
Supplement: S001
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2001-04-04
Decision code: APPR
Date received: 1999-04-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.