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 3PC MULTIFOCAL |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P080010 |
Supplement Number | S012 |
Date Received | 12/18/2015 |
Decision Date | 01/12/2016 |
Product Code |
MFK |
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 TO ADD 2 NEW CONTRACTORS TO PURIFY THE MONOMERS AND CROSS-LINKERS TO PRODUCE THE SILICONE MATERIAL USED IN THE ABOVE INTRAOCULAR LENSES. |
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