Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | TRULIGN TORIC WEB BASED TORIC CALCULATOR |
Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S036 |
Date Received | 12/15/2015 |
Decision Date | 02/17/2016 |
Product Code |
MJP |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for software changes to the web-based toric calculator (WBTC) used with the Trulign Toric IOL. |
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