PMA P950018S001
- Device
- PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
- Applicant
- Alcon Laboratories
- PMA number
- P950018
- Supplement
- S001
- Product code
- LWL
- Decision date
- 1996-12-11
- Classification
- Fluid, Intraocular
- Generic name
- Fluid, intraocular
- 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
Current openFDA PMA Record#
- Device
- PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID)
- Applicant
- Alcon Laboratories
- PMA number
- P950018
- Supplement
- S001
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 1996-12-11
- Decision code
- APPR
- Date received
- 1996-10-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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