PERFLUOROPROPANE FOR PNEUMATIC RETINOPEXY
FDA premarket approval P900066/S006 · decided 2002-12-10
Approval details
- PMA number
- P900066
- Supplement
- S006
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process 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
- 2002-08-13
- Decision date
- 2002-12-10
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- APPROVAL TO ADD A MOLECULAR SIEVE SCRUBBING STEP AT THE END OF THE GAS MANUFACTURING PROCESS.
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