CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
FDA premarket approval P030002/S008 · decided 2007-05-24
Approval details
- PMA number
- P030002
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2006-07-24
- Decision date
- 2007-05-24
- Days to decision
- 304 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- PERFORM MOIST HEAT STERILIZATION IN HOUSE AT EYEONICS? RANCHO CUCAMONGA FACILITY.
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