SILICOM(TM) 1000 RETINALTAMPONADE
FDA premarket approval P950008/S012 · decided 2014-11-03
Approval details
- PMA number
- P950008
- Supplement
- S012
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SILICOM(TM) 1000 RETINALTAMPONADE
- Generic name
- Fluid, intraocular
- Applicant
- Alcon
- Date received
- 2014-07-07
- Decision date
- 2014-11-03
- Days to decision
- 119 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN FORT WORTH, TEXAS.
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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 |