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 ACRYLIC INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990080 |
Supplement Number | S043 |
Date Received | 06/02/2016 |
Decision Date | 07/29/2016 |
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 Change in the Bioburden Test Method used in the manufacturing of the TECNIS CL, Model Z9002, SENSAR Acrylic Intraocular Lenses (IOLs), Models AR40, AAB00, ZCB00, ZCB00V, and ZMB00, and TECNIS Acrylic Monofocal IOL, Model ZA9003. |
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