EN VISTA ONE PIECE HYDROPHOBIC ACRYLIC LENS
FDA premarket approval P910056/S017 · decided 2014-08-01
Approval details
- PMA number
- P910056
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EN VISTA ONE PIECE HYDROPHOBIC ACRYLIC LENS
- Generic name
- intraocular lens
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2014-05-05
- Decision date
- 2014-08-01
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A PACKAGING CHANGE AND AN EXTENSION OF THE SHELF LIFE OF THE DEVICE IN THE NEW PACKAGING CONFIGURATION FROM 14 TO 36 MONTHS.
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