TECNIS iTEC Preloaded Delivery System
FDA premarket approval P980040/S106 · decided 2019-09-11
Approval details
- PMA number
- P980040
- Supplement
- S106
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS iTEC Preloaded Delivery System
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2019-08-19
- Decision date
- 2019-09-11
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of an alternate supplier for the nut component used for the TECNIS® 1-Piece Intraocular Lens (IOL) with the TECNIS® iTEC Preloaded Delivery System, Model PCB00 and TECNIS® Multifocal 1-Piece IOL with the TECNIS® iTEC Preloaded Delivery System, Model PMB00.
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