ANTERIOR CHAMBER INTRAOCULAR LENSES
FDA premarket approval P850059/S018 · decided 1998-12-28
Approval details
- PMA number
- P850059
- Supplement
- S018
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTERIOR CHAMBER INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb Surgical, Inc.
- Date received
- 1998-10-29
- Decision date
- 1998-12-28
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- Approval for use of an alternate sterilization chamber at Griffith MicroScience.
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