TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA
FDA premarket approval P980040/S051 · decided 2014-11-12
Approval details
- PMA number
- P980040
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, TECNIS MULTIFOCAL 1-PIECE IOL WITH THE TECNIS ITEC PRELOA
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2014-10-16
- Decision date
- 2014-11-12
- Days to decision
- 27 days
- Decision code
- OK30
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- ADDING AN ALTERNATE MOLDING SUPPLIER FOR THE CARTRIDGE COMPONENT USED IN THE TECNIS ITEC PRELOAD DELIVERY SYSTEM.
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