ADATO SIL-OL 5000 SILICONE OIL
FDA premarket approval P910071/S011 · decided 2008-05-20
Approval details
- PMA number
- P910071
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADATO SIL-OL 5000 SILICONE OIL
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2007-12-17
- Decision date
- 2008-05-20
- Days to decision
- 155 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PHARMPUR GMBH, KONIGSBRUNN, GERMANY86343
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