ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)
FDA premarket approval P010027 · decided 2001-11-21
Approval details
- PMA number
- P010027
- Trade name
- ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)
- Generic name
- intraocular lens
- Applicant
- Aaren Scientific
- Date received
- 2001-04-30
- Decision date
- 2001-11-21
- Days to decision
- 205 days
- Decision code
- APWD
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR THE ALLERGAN, INC. MODEL AC21B ULTRAVIOLET-ABSORBING PMMA ANTERIOR CHAMBER INTRAOCULAR LENS, AVAILABLE IN THREE OVERALL DIAMETERS (12.0 MM, 13.0 MM, 14.0 MM). THE APPLICATION IS A LICENSING PMA IN WHICH ALLERGAN, INC. HAS GIVING OPHTHALMIC INNOVATIONS INTERNATIONAL, INC. REFERENCE RIGHTS TO P860034. ADDITIONALLY, IT IS REQUESTED THAT ALLERGAN, INC. DISTRIBUTE THE LENS AS THE DURALENS II MODEL AC21B. THE DEVICE IS INDICATED FOR THE REPLACEMENT OF THE HUMAN LENS IN THE VISUAL CORRECTI
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