TECNIS Symfony Toric IOL
FDA premarket approval P980040/S093 · decided 2018-11-14
Approval details
- PMA number
- P980040
- Supplement
- S093
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- TECNIS Symfony Toric IOL
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2018-09-19
- Decision date
- 2018-11-14
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval of revisions to the post-approval study (PAS) protocol.
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