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 | TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL) WITH THE TECNIS ITEC PRELOADED DELIVERY SYSTEM |
Generic Name | LENS, INTRAOCULAR, TORIC OPTICS |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S056 |
Date Received | 12/24/2014 |
Decision Date | 03/17/2015 |
Product Code |
MJP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE PACKAGING OF THE MODEL SERIES ZCT INTRAOCULAR LENSES (IOL) FROM A WHEELCASE CONFIGURATION TO A PRELOADED PACKAGING CONFIGURATION/DELIVERY SYSTEM. THE PRELOADED LENS MODELS WILL BE BRANDED UNDER THE NAME ¿TECNIS® TORIC 1-PIECE IOL WITH TECNIS ITEC PRELOADED DELIVERY SYSTEM, MODELS PCT150, PCT225, PCT300 AND PCT400.¿ |
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