ADATO SIL-OL 5000 SILICONE OIL
FDA premarket approval P910071/S010 · decided 2007-12-12
Approval details
- PMA number
- P910071
- Supplement
- S010
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADATO SIL-OL 5000 SILICONE OIL
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 2007-07-11
- Decision date
- 2007-12-12
- Days to decision
- 154 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A PACKAGING CHANGE WHICH INVOLVES THE ADDITION OF A RIGID TIP CAP TO THE 10 CC GLASS SYRINGE PACKAGING CONFIGURATION TO INCORPORATE A RIGID POLYPROPYLENE HOUSING AROUND THE ELASTOMER SEAL.
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