|
Device | TECHNOLAS 217A EXCIMER LASER AND TEHNOLAS 217Z ZYOPTIX SYSTEMS |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR 1 + 3 MUNCHEN 80992 |
PMA Number | P990027 |
Supplement Number | S019 |
Date Received | 01/31/2014 |
Decision Date | 02/27/2014 |
Product Code |
LZS |
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 REPLACEMENT OF THE CAPACITOR AND DIAGNOSTIC MONITOR. |