TECNIS ITEC PRELOADED DELIVERY SYSTEM
FDA premarket approval P980040/S041 · decided 2013-08-21
Approval details
- PMA number
- P980040
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TECNIS ITEC PRELOADED DELIVERY SYSTEM
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2012-09-04
- Decision date
- 2013-08-21
- Days to decision
- 351 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A CHANGE IN THE PACKAGING CONFIGURATION/ DELIVERY SYSTEM FOR THE TECNIS® 1-PIECE INTRAOCULAR LENS (IOL), MODEL ZCB00. THE NEW PACKAGING CONFIGURATION WILL FUNCTION AS BOTH THE PRIMARY PACKAGING FOR THE LENS AND AS A STERILE, DISPOSABLE INSERTION SYSTEM FOR DELIVERING THE LENS INTO THE EYE. THE TECNIS® 1-PIECE IOL (MODEL ZCB00) IN THE NEW PACKAGING CONFIGURATION/ DELIVERY SYSTEM IS DESIGNATED THE TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODEL PCB00, AND IS INDICATED FOR THE VISUAL CORR
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