POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
FDA premarket approval P790027/S060 · decided 1999-05-13
Approval details
- PMA number
- P790027
- Supplement
- S060
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POSTERIOR & ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb
- Date received
- 1998-08-07
- Decision date
- 1999-05-13
- Days to decision
- 279 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR A MANUFACTURING AND STERILIZATION FACILITY LOCATED AT BAUSCH & LOMB SURGICAL, INC. CLEARWATER, FLORIDA.
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