| 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 | SILIKON 1000 |
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| Generic Name | Fluid, intraocular |
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| Regulation Number | 886.4275 |
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| Applicant | Alcon
6201 S. Freeway
Mail Drop R7-14
Fort Worth, TX 76134-2099 |
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| PMA Number | P950008 |
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| Date Received | 02/22/1995 |
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| Decision Date | 09/25/1997 |
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| Product Code |
LWL |
| Docket Number | 97M-0521 |
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| Notice Date | 09/30/1997 |
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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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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the SILIKON 1000. This device is indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. Complicated retinal detachments or recurrent retinal detachments occur most commonly in eyes with proliferative vitreoretinopathy (PVR), proliferative diabetic retinopathy (PDR), cytomegalovirus (CMV) retinitis, giant tears, and following perofrating injuries. SILIKON 1000 is also indicated for primary use in detachments due to AIDS) related CMV retinitis and other viral infections affecting the retina. |
| Supplements: |
S012 S006 S002 S008 S007 S009 S001 S004 S011 S010 S003
S013 S016 S017 S021 S023 S014 S015 S018 S019 S022 |
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