ADATO SIL 5000
FDA premarket approval P910071/S002 · decided 1995-07-14
Approval details
- PMA number
- P910071
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- ADATO SIL 5000
- Generic name
- Fluid, intraocular
- Applicant
- Bausch & Lomb
- Date received
- 1994-12-28
- Decision date
- 1995-07-14
- Days to decision
- 198 days
- Decision code
- APPR
- Product code
- LWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A PROTOCOL FOR A POSTAPPROVAL PROSPECTIVE STUDY
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