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 FOLDABLE ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003 |
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 | S024 |
Date Received | 05/09/2007 |
Decision Date | 07/16/2007 |
Product Code |
HQL |
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 TO ADD AN ALTERNATE MANUFACTURING SITE, A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO. |
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