TECNIS 3-Piece Acrylic Monofocal
FDA premarket approval P990080/S048 · decided 2019-01-15
Approval details
- PMA number
- P990080
- Supplement
- S048
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS 3-Piece Acrylic Monofocal
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-12-21
- Decision date
- 2019-01-15
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Changing an in-process sampling procedure for buttons used to manufacture 1-piece and 3-piece IOLs.
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