TECNIS Toric 1-Piece IOL Model ZCT
FDA premarket approval P980040/S079 · decided 2017-03-24
Approval details
- PMA number
- P980040
- Supplement
- S079
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Toric 1-Piece IOL Model ZCT
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2017-02-23
- Decision date
- 2017-03-24
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Addition of the AMO Kulim, Malaysia manufacturing site for the production of your TECNIS Toric IOL Models ZCT150, ZCT225, ZCT300, ZCT375, ZCT400, ZCT450, ZCT525, and ZCT600.
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