PMA P980031S002

Device: INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
Applicant: Addition Technology
PMA number: P980031
Supplement: S002
Product code: LQE
Decision date: 2000-01-12
Classification: Implant, Corneal, Refractive
Generic name: Implant, corneal, refractive
Approval order statement: The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.

Current openFDA PMA Record#

Device: INTACS (INTRASTROMAL CORNEAL RING SEGMENTS)
Applicant: Addition Technology
PMA number: P980031
Supplement: S002
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2000-01-12
Decision code: OK30
Date received: 1999-12-23
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-day notice requested the implementation of a qualified sampling plan for dimensional inspection of the product attributes: width, arc length, outside diameter, symmetry and hole placement.