CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMMODATING INTRAOCULAR LENS (IOL)
FDA premarket approval P030002/S001 · decided 2004-08-16
Approval details
- PMA number
- P030002
- Supplement
- S001
- Supplement type
- Real-Time Process
- Trade name
- CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMMODATING INTRAOCULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2004-06-28
- Decision date
- 2004-08-16
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PHYSICIAN'S LABELING.
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