TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
FDA premarket approval P980040/S046 · decided 2014-04-28
Approval details
- PMA number
- P980040
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS MULTIFOCAL 1-PIECE INTRAOCULAR LENS WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2013-10-17
- Decision date
- 2014-04-28
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A CHANGE IN THE PACKAGING/DELIVERY SYSTEM FOR THE TECNIS®MULTIFOCAL 1-PIECE INTRAOCULAR LENS, MODEL ZMB00. THE TECNIS® MULTIFOCAL 1-PIECE INTRAOCULAR LENS IN THE NEW PACKAGING/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADEDDELIVERY SYSTEM, MODEL PMB00, AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS WITH AND WITHOUT PRESBYOPIA IN WHOM A CATARACTOUS LENSHAS BEEN REMOVED BY PHACOEMULSIFICATION AND WHO DESIRE NEAR, INTERMEDIATE,
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