PMA P980031S001

Device: INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
Applicant: Addition Technology
PMA number: P980031
Supplement: S001
Product code: LQE
Decision date: 1999-11-29
Classification: Implant, Corneal, Refractive
Generic name: Implant, corneal, refractive
Approval order statement: The 30-day Notice requested the implementation of the View Engineering voyage Model V1212 Dimensional Non-contact Measurement system for the inspection of thickness, width and symmetry of the Intacs(TM) (Intrastromal Corneal Ring Segements).

Current openFDA PMA Record#

Device: INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
Applicant: Addition Technology
PMA number: P980031
Supplement: S001
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 1999-11-29
Decision code: OK30
Date received: 1999-11-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day Notice requested the implementation of the View Engineering voyage Model V1212 Dimensional Non-contact Measurement system for the inspection of thickness, width and symmetry of the Intacs(TM) (Intrastromal Corneal Ring Segements).