CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMODATING INTRAOCULAR LENS (IOL)
FDA premarket approval P030002/S002 · decided 2004-09-29
Approval details
- PMA number
- P030002
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Other
- Trade name
- CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMODATING INTRAOCULAR LENS (IOL)
- Generic name
- Lens, intraocular, accommodative
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2004-08-30
- Decision date
- 2004-09-29
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- NAA
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MODIFY THE DEVICE DESCRIPTION IN THE PHYSICIAN LABELING.
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