Silikon 1000
FDA premarket approval P950008/S016 · decided 2023-08-02
Approval details
- PMA number
- P950008
- Supplement
- S016
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Silikon 1000
- Generic name
- Fluid, intraocular
- Applicant
- Alcon
- Date received
- 2023-02-01
- Decision date
- 2023-08-02
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval to implement the single re-use of the polishing filter on two bulk batches of Silikon 1000 (silicone oil) during the compounding process.
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 |