PMA P980031S005

Device: INTACS PRESCRIPTION INSERTS
Applicant: Addition Technology
PMA number: P980031
Supplement: S005
Product code: LQE
Decision date: 2003-05-30
Classification: Implant, Corneal, Refractive
Generic name: Implant, corneal, refractive
Approval order statement: IMPLEMENTING THE OUTSOURCING OF THE INSPECTION, CLEANING AND PACKAGING OPERATIONS FOR INTACS INSERTS TO THE QUALIFIED CONTRACT MANUFACTURER, BIOTEST LABORATORIES, INC.

Current openFDA PMA Record#

Device: INTACS PRESCRIPTION INSERTS
Applicant: Addition Technology
PMA number: P980031
Supplement: S005
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2003-05-30
Decision code: OK30
Date received: 2003-05-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: IMPLEMENTING THE OUTSOURCING OF THE INSPECTION, CLEANING AND PACKAGING OPERATIONS FOR INTACS INSERTS TO THE QUALIFIED CONTRACT MANUFACTURER, BIOTEST LABORATORIES, INC.