| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy |
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| Generic Name | Gases used within eye to place pressure on detached retina |
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| Regulation Number | 886.4270 |
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| Applicant | Alcon Research, LLC.
20511 Lake Forest Drive
Lake Forest, CA 92630 |
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| PMA Number | P230012 |
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| Date Received | 03/21/2023 |
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| Decision Date | 08/26/2024 |
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| Product Code |
LPO |
| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. The UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, laser photocoagulation, and air/gas exchange.The UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, and laser photocoagulation. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 |
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