PMA P900066S004
- Device
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S004
- Product code
- LPO
- Decision date
- 2000-09-05
- 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 FOR A CHANGE TO THE TOXICITY TEST PROTOCOL TO INCREASE THE NUMBER OF SAMPLES TO BE TESTED FROM EACH PRODUCTION LOT OF PERFLUOROPROPANE FROM ONE SAMPLE PER LOT TO THREE SAMPLES PER LOT.
Current openFDA PMA Record#
- Device
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Applicant
- Airgas Therapeutics, LLC
- PMA number
- P900066
- Supplement
- S004
- Product code
- LPO
- Generic name
- Gases used within eye to place pressure on detached retina
- Decision date
- 2000-09-05
- Decision code
- APPR
- Date received
- 2000-08-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TOXICITY TEST PROTOCOL TO INCREASE THE NUMBER OF SAMPLES TO BE TESTED FROM EACH PRODUCTION LOT OF PERFLUOROPROPANE FROM ONE SAMPLE PER LOT TO THREE SAMPLES PER LOT.