PMA P900066S003
- Device
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S003
- Product code
- LPO
- Decision date
- 2000-03-16
- 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
- 1)Change in manufacturing site; 2)Alternate synthesis route for perfluoropropane; and 3) Changing release specification for the perfluoropropane gas.
Current openFDA PMA Record#
- Device
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S003
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2000-03-16
- Decision code
- APPR
- Date received
- 1999-09-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- 1)Change in manufacturing site; 2)Alternate synthesis route for perfluoropropane; and 3) Changing release specification for the perfluoropropane gas.