CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
FDA premarket approval P030002/S011 · decided 2007-05-25
Approval details
- PMA number
- P030002
- Supplement
- S011
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2007-04-25
- Decision date
- 2007-05-25
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGE IN THE TUMBLING AND PRE-CLEANING PROCESS FOR THE DEVICE.
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