PMA P980040S022

Device
TECNIS 1-PIECE IOL MODEL ZCB00
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S022
Product code
HQL
Decision date
2008-02-01
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE AT A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.

Current openFDA PMA Record#

Device
TECNIS 1-PIECE IOL MODEL ZCB00
Applicant
Johnson & Johnson Surgical Vision, Inc.
PMA number
P980040
Supplement
S022
Product code
HQL
Generic name
intraocular lens
Decision date
2008-02-01
Decision code
APPR
Date received
2007-12-21
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 AT A.M.O. PUERTO RICO MANUFACTURING, INC., ANASCO, PUERTO RICO.