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 | CRYSTALENS AND TRULIGN TORIC INTRAOCULAR LENSES (IOLS) |
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 | S035 |
Date Received | 07/02/2015 |
Decision Date | 03/24/2016 |
Product Code |
MJP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Bausch & Lomb, Incorporated, 21 Park Place Boulevard North, Clearwater, Florida 33759 as an alternate manufacturing facility for the Crystalens and Trulign IOLs. |
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