Tecnis 3-piece Multifocal
FDA premarket approval P080010/S015 · decided 2018-05-09
Approval details
- PMA number
- P080010
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tecnis 3-piece Multifocal
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-04-11
- Decision date
- 2018-05-09
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Sterilization of the intraocular lens products manufactured at the Johnson & Johnson Vision Care manufacturing facility in Puerto Rico using vessel #4 and hot cell #5.
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