|
Device | TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS |
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 | S002 |
Date Received | 04/28/2009 |
Decision Date | 06/19/2009 |
Product Code |
MFK |
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 FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO. |