CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)
FDA premarket approval P030002/S013 · decided 2007-12-12
Approval details
- PMA number
- P030002
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2007-11-05
- Decision date
- 2007-12-12
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR INCLUSION OF THE MICROSTAAR MSI-PR AND MSI-TR INJECTORS AND MTC-60C CARTRIDGE IN THE PHYSICIAN LABELING FOR THE CRYSTALENS MODELS AT-50SE AND AT-52SE.
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