ISPAN Perfluoropropane C3F8 Gas
FDA premarket approval P900066/S014 · decided 2022-08-04
Approval details
- PMA number
- P900066
- Supplement
- S014
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ISPAN Perfluoropropane C3F8 Gas
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 2021-09-21
- Decision date
- 2022-08-04
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- Approval to replace the gas chromatograph used to complete in-process quality testing during the distillation of the bulk perfluoropropane gas.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |