SILIKON 1000
FDA premarket approval P950008 · decided 1997-09-25
Approval details
- PMA number
- P950008
- Trade name
- SILIKON 1000
- Generic name
- Fluid, intraocular
- Applicant
- Alcon
- Date received
- 1995-02-22
- Decision date
- 1997-09-25
- Days to decision
- 946 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Fort Worth, TX
- 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 als
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ALCON VISION SYSTEM (K063583) | Alcon | 2008-05-09 |
| OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION (K981574) | Alcon | 1998-07-06 |