POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
FDA premarket approval P880090/S026 · decided 2009-07-31
Approval details
- PMA number
- P880090
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2009-06-19
- Decision date
- 2009-07-31
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE BLOW-OFF PROCESS IN THE AIR DRYING OF THE POLYMETHYLMETHACRYLATE LENSES.
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