| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | VITREON(R) |
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| Classification Name | fluid, intraocular |
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| Generic Name | perfluorocarbon liquid |
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| Regulation Number | 886.4275 |
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| Applicant | AIR PRODUCTS & CHEMICALS, INC. |
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| PMA Number | P910068 |
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| Date Received | 12/06/1991 |
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| Decision Date | 09/30/1997 |
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Withdrawal Date
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06/27/2003 |
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| Product Code | |
| Docket Number | 97M-0519 |
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| Notice Date | 01/02/1998 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | Yes |
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| Combination Product |
No
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Approval Order Statement
Approval for vitreon(r) (perfluorophenanthrene) intraocular fluid. This device is indicated for use as an intraoperative surgical aid during vitreoretinal surgery inpatients with primary and recurrent complicated reinal detachments. Complicated cases include giant retinal tear or retinal dialysis, proliferative vitreoretinopathy, proliferative diabetic reinopathy, tractional retinal detachments, and blunt or penetrating ocular trauma. We are pleased to inform you that the pma is approved for a single batch (batch #672-45-0001) of the finished product packaged in sterile 6 ml vials. |
| Supplements: |
S001 |
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