AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
FDA premarket approval P060022/S012 · decided 2012-06-18
Approval details
- PMA number
- P060022
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Trade name
- AKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2011-06-21
- Decision date
- 2012-06-18
- Days to decision
- 363 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE PRIMARY PACKAGING WHICH INCLUDES AN ALTERNATE PLASTIC VIAL AND INTRAOCULAR LENS (IOL) HOLDER.
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