PMA P980031S007

Device
INTACS PRESCRIPTION INSERTS
Applicant
Addition Technology
PMA number
P980031
Supplement
S007
Product code
LQE
Decision date
2007-08-21
Classification
Implant, Corneal, Refractive
Generic name
Implant, corneal, refractive
Approval order statement
APPROVAL FOR PACKAGING OPERATIONS FOR THE INTACS PRESCRIPTION INSERTS TO BE TRANSFERRED TO THE SUNNYVALE, CALIFORNIA FACILITY.

Current openFDA PMA Record#

Device
INTACS PRESCRIPTION INSERTS
Applicant
Addition Technology
PMA number
P980031
Supplement
S007
Product code
LQE
Generic name
Implant, corneal, refractive
Decision date
2007-08-21
Decision code
APPR
Date received
2004-05-19
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR PACKAGING OPERATIONS FOR THE INTACS PRESCRIPTION INSERTS TO BE TRANSFERRED TO THE SUNNYVALE, CALIFORNIA FACILITY.