|
Device | WAVESCAN WAVEFRONT SYSTEM |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S038 |
Date Received | 05/28/2013 |
Decision Date | 06/27/2013 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE WAVESCAN WAVEFRONT SYSTEM DEVICE LABELING (USER MANUAL). |