PMA P950018S007

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S007
Product code: LWL
Decision date: 2001-08-07
Generic name: Fluid, intraocular
Approval order statement: ELIMINATION OF FINISHED PRODUCT INTRAVITREAL TESTING FOR PERFLUORON AND REVISION OF THE "PURIFIED PERFLUORO-N-OCTANE ANALYTICAL TEST MONOGRAPH" REGARDING CALCULATION OF IMPURITIES. THE SPECIFICATION OF >=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED.

Current openFDA PMA Record#

Device: PERFLUORON
Applicant: Alcon Laboratories
PMA number: P950018
Supplement: S007
Product code: LWL
Generic name: Fluid, intraocular
Decision date: 2001-08-07
Decision code: OK30
Date received: 2001-07-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ELIMINATION OF FINISHED PRODUCT INTRAVITREAL TESTING FOR PERFLUORON AND REVISION OF THE "PURIFIED PERFLUORO-N-OCTANE ANALYTICAL TEST MONOGRAPH" REGARDING CALCULATION OF IMPURITIES. THE SPECIFICATION OF >=99.9% FOR PURIFIED PERFLUORO-N-OCTANE REMAINS UNCHANGED.