ISPAN TM PERFLUOROPROPANE (C3F8)GAS
FDA premarket approval P900066/S002 · decided 1996-09-24
Approval details
- PMA number
- P900066
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ISPAN TM PERFLUOROPROPANE (C3F8)GAS
- Generic name
- Gases used within eye to place pressure on detached retina
- Applicant
- Airgas Therapeutics, LLC
- Date received
- 1996-08-23
- Decision date
- 1996-09-24
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LPO
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Plumsteadville, PA
- Statement
- APPROVAL TO ADD A 20 GRAM AND A 125 GRAM ALUMINUM LECTURE BOTTLE SIZE FOR THE REFERENCED DEVICES.
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510(k) clearances by this applicant
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|---|---|---|
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |