ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P910056/S006 · decided 1997-05-07
Approval details
- PMA number
- P910056
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 1997-03-06
- Decision date
- 1997-05-07
- Days to decision
- 62 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR REVISED LABELING.
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