CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS
FDA premarket approval P030002/S024 · decided 2011-09-08
Approval details
- PMA number
- P030002
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2011-07-14
- Decision date
- 2011-09-08
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MODIFY THE LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE +17 TO +27 POWER RANGE FOR THE CRYSTALENS ACCOMMODATING INTRAOCULAR LENS, MODEL AT52AO.
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