PMA P900066S006
- Device
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S006
- Product code
- LPO
- Decision date
- 2002-12-10
- Classification
- Gases Used Within Eye To Place Pressure On Detached Retina
- Generic name
- Gases used within eye to place pressure on detached retina
- Approval order statement
- APPROVAL TO ADD A MOLECULAR SIEVE SCRUBBING STEP AT THE END OF THE GAS MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S006
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2002-12-10
- Decision code
- APPR
- Date received
- 2002-08-13
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO ADD A MOLECULAR SIEVE SCRUBBING STEP AT THE END OF THE GAS MANUFACTURING PROCESS.