PMA P080010S002

Device
TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P080010
Supplement
S002
Product code
MFK
Decision date
2009-06-19
Classification
Lens, Multifocal Intraocular
Generic name
Lens, multifocal intraocular
Approval order statement
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.

Current openFDA PMA Record#

Device
TECNIS MULTIFOCAL FOLDABLE ACRYLIC INTRAOCULAR LENS
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P080010
Supplement
S002
Product code
MFK
Generic name
Lens, multifocal intraocular
Decision date
2009-06-19
Decision code
APPR
Date received
2009-04-28
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE LOCATED AT AMO PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.