ADATO SIL-OL 5000 SILICONE OIL
FDA premarket approval P910071/S016 · decided 2016-01-15
Approval details
- PMA number
- P910071
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADATO SIL-OL 5000 SILICONE OIL
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2015-11-19
- Decision date
- 2016-01-15
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR SHELF LIFE EXTENSION FOR THE ADATO® SIL-OL 5000 SILICONE OIL.
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| STELLARIS VISION ENHANCEMENT SYSTEM (K133242) | Bausch & Lomb | 2014-02-14 |
| BAUSCH & LOMB INJECTOR SYSTEM (K131958) | Bausch & Lomb | 2014-01-09 |
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