Sensar/Tecnis 1-Piece IOL, Tecnis Toric IOL, Tecnis Symfony Extended Range of Vision IOL, Tecnis Symfony Toric Extended
FDA premarket approval P980040/S089 · decided 2018-09-26
Approval details
- PMA number
- P980040
- Supplement
- S089
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sensar/Tecnis 1-Piece IOL, Tecnis Toric IOL, Tecnis Symfony Extended Range of Vision IOL, Tecnis Symfony Toric Extended
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-05-04
- Decision date
- 2018-09-26
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for modifications to the cryotumbling process.
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