ISPAN SULFUR HEXAFLUORIDE SF6 GAS
FDA premarket approval P900067/S005 · decided 2008-12-09
Approval details
- PMA number
- P900067
- Supplement
- S005
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISPAN SULFUR HEXAFLUORIDE SF6 GAS
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 2008-11-09
- Decision date
- 2008-12-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- CHANGE OF SULFUR HEXAFLUORIDE GAS SUPPLIER.
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