PMA P900066S010
- Device
- ISPAN PERFLUOROPROPANE C3F8 GAS
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S010
- Product code
- LPO
- Decision date
- 2010-08-18
- Generic name
- Gases used within eye to place pressure on detached retina
- Approval order statement
- CHANGE OF THE CLEANING SOLVENT USED IN THE PERFLUOROPROPANE GAS MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- ISPAN PERFLUOROPROPANE C3F8 GAS
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S010
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2010-08-18
- Decision code
- OK30
- Date received
- 2010-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE OF THE CLEANING SOLVENT USED IN THE PERFLUOROPROPANE GAS MANUFACTURING PROCESS.