|
Device | TECNIS MULTIFOCAL SILICONE IOL/MODEL ZM900 & THE TECNIS MULTIFOCAL FOLDABLE ACRYLIC IOL 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 | S003 |
Date Received | 06/09/2009 |
Decision Date | 07/17/2009 |
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 CHANGE IN THE STERILIZATION PROCESS PARAMETERS FOR THE DEVICE. |