Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK) |
Generic Name | Excimer laser system |
Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI 443-0-0038 |
PMA Number | P970053 |
Supplement Number | S001 |
Date Received | 02/16/1999 |
Decision Date | 09/29/1999 |
Product Code |
LZS |
Docket Number | 00M-1664 |
Notice Date | 12/13/2000 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Nidek EC-5000 Excimer Laser System for Photorefractive Keratectomy for Moderate Myopia with Astigmatism. This device is intended for use in: 1) the reduction or elimination of myopia with astigmatism raning in severity from -1.00 to -8.00 diopters (D), in terms of manifest refraction spherical equivalent (MRSE), with refractive astigmatism ranging in severity from -0.5 to -4.00 D cylinder by manifest refraction; due to cylinder coupling effects on sphere, the lower range of the intended use must be restricted in a step-wise fashion. A nomogram lookup table is provided for specific treatment combinations. 2) patients who have a stable history of both pretreatment myopic astigmatism (i.e., magnitude of change in manifest refraction of <0.5D per year in terms of MRSE for at least one year proceeding treatment) and pretreatment astigmatism (i.e., a magnitude of change of <0.5D per year in cylinder for at least one year preceding treatment); and 3) patients who are over 21 years of age. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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