PMA P980031S009

Device: INTACS PRESCRIPTION INSERTS
Applicant: Addition Technology
PMA number: P980031
Supplement: S009
Product code: LQE
Decision date: 2005-11-23
Classification: Implant, Corneal, Refractive
Generic name: Implant, corneal, refractive
Approval order statement: TRANSFER OF NON-CRITICAL "AS/MANUFACTURED" DIMENSIONAL INSPECTIONS OF WIDTH, SYMMETRY, OUTER DIAMETER, ARC LENGTH, AND DRILL HOLE PLACEMENT FOR MACHINED INTACS PRESCRIPTION INSERTS FROM BIOTEST LABORATORIES TO OCULAR TECHNOLOGY INC.

Current openFDA PMA Record#

Device: INTACS PRESCRIPTION INSERTS
Applicant: Addition Technology
PMA number: P980031
Supplement: S009
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2005-11-23
Decision code: OK30
Date received: 2005-10-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: TRANSFER OF NON-CRITICAL "AS/MANUFACTURED" DIMENSIONAL INSPECTIONS OF WIDTH, SYMMETRY, OUTER DIAMETER, ARC LENGTH, AND DRILL HOLE PLACEMENT FOR MACHINED INTACS PRESCRIPTION INSERTS FROM BIOTEST LABORATORIES TO OCULAR TECHNOLOGY INC.