CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)
FDA premarket approval P030002/S019 · decided 2009-06-30
Approval details
- PMA number
- P030002
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2009-05-01
- Decision date
- 2009-06-30
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MODIFY THE PHYSICIAN¿S LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE CRYSTALENS MODEL HD500 AND HD520 AS FOLLOWS: THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR MODEL HD500 LENSES IN THE +18 TO +22 DIOPTRIC POWER RANGE AND FOR MODEL HD520 LENSES IN THE +16.25 TO +16.75 DIOPTRIC POWER RANGE.
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| BAUSCH & LOMB IOL INJECTOR (K113852) | Bausch & Lomb, Inc. | 2012-09-28 |
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