PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
FDA premarket approval P900066/S003 · decided 2000-03-16
Approval details
- PMA number
- P900066
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 1999-09-21
- Decision date
- 2000-03-16
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- 1)Change in manufacturing site; 2)Alternate synthesis route for perfluoropropane; and 3) Changing release specification for the perfluoropropane gas.
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