|
Device | TECNIS MULTIFOCAL LENS MODEL ZMA00 |
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 | S007 |
Date Received | 01/30/2012 |
Decision Date | 02/29/2012 |
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 IMPLEMENT A SOFTWARE AND HARDWARE UPGRADE TO THE EQUIPMENT USED TO MEASURE OPTICAL PROPERTIES OF INTRA- OCULAR LENSES. |