ADATO SIL 5000
FDA premarket approval P910071/S004 · decided 1997-12-24
Approval details
- PMA number
- P910071
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- ADATO SIL 5000
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 1997-07-08
- Decision date
- 1997-12-24
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Requested that a Phase IV trial of AdatoSil 5000(TM) no longer be required as a condition of approval for this PMA, and that the current labeling be revised to state more specificaly the role of the physician in determining the use and removal of AdatoSil 5000(TM) silicone oil.
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