TECNIS TORIC 1-PIECE INTRAOCULAR LENS
FDA premarket approval P980040/S062 · decided 2015-08-25
Approval details
- PMA number
- P980040
- Supplement
- S062
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- TECNIS TORIC 1-PIECE INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-04-02
- Decision date
- 2015-08-25
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDYPROTOCOL.
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