PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
FDA premarket approval P900066/S004 · decided 2000-09-05
Approval details
- PMA number
- P900066
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Postapproval Study Protocol
- Trade name
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 2000-08-18
- Decision date
- 2000-09-05
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- 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.
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