Silikon 1000

FDA premarket approval P950008 · Fluid, intraocular

PMA numberP950008

Approval

Applicant
Alcon
Received
February 22, 1995
Decision date
September 25, 1997 (APPR)
Supplements
21, latest June 3, 2024
Product code
LWL – Fluid, Intraocular

Official FDA PMA record

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.