TECNIS Toric II 1-Piece Intraocular Lenses and TECNIS Symfony Toric II Extended Range of Vision Introacular Lensses
FDA premarket approval P980040/S103 · decided 2019-10-23
Approval details
- PMA number
- P980040
- Supplement
- S103
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TECNIS Toric II 1-Piece Intraocular Lenses and TECNIS Symfony Toric II Extended Range of Vision Introacular Lensses
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2019-04-17
- Decision date
- 2019-10-23
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modification of the manufacturing resulting in squared and frosted haptics.
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