|
Device | INTACS (INTRASTROMAL CORNEAL RING SEGMENTS) |
Generic Name | Implant, corneal, refractive |
Applicant | ADDITION TECHNOLOGY 820 OAK CREEK DRIVE LOMBARD, IL 60148 |
PMA Number | P980031 |
Supplement Number | S001 |
Date Received | 11/03/1999 |
Decision Date | 11/29/1999 |
Product Code |
LQE |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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). |