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 | SENSAR® 1-Piece IOL, Model AAB00, TECNIS® Monofocal 1-Piece IOL, Model ZCB00, TECNIS® Multifocal 1-Piece IOL, Model ZMB0 |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S152 |
Date Received | 10/25/2022 |
Decision Date | 11/17/2022 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Expansion of the manufacturing facility in building 3 of the Puerto Rico facility. |
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