Silikon 1000
FDA premarket approval P950008/S015 · decided 2021-02-15
Approval details
- PMA number
- P950008
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Silikon 1000
- Generic name
- Fluid, intraocular
- Applicant
- Alcon
- Date received
- 2021-01-19
- Decision date
- 2021-02-15
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Implementation of an alternate indicator for demonstrating successful terminal sterilization for Silikon 1000.
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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 |