TRULIGN TORIC WEB BASED TORIC CALCULATOR
FDA premarket approval P030002/S036 · decided 2016-02-17
Approval details
- PMA number
- P030002
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRULIGN TORIC WEB BASED TORIC CALCULATOR
- Generic name
- LENS, INTRAOCULAR, TORIC OPTICS
- Applicant
- Bausch & Lomb, Inc.
- Date received
- 2015-12-15
- Decision date
- 2016-02-17
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MJP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- Approval for software changes to the web-based toric calculator (WBTC) used with the Trulign Toric IOL.
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