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 |
Generic Name | Excimer laser system |
Applicant | NIDEK CO., LTD. 34-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI 443-0-0038 |
PMA Number | P970053 |
Supplement Number | S002 |
Date Received | 04/19/1999 |
Decision Date | 04/14/2000 |
Product Code |
LZS |
Docket Number | 01M-0014 |
Notice Date | 01/16/2001 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | Yes |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement INDICATIONS FOR USE OF THE NIDEK EC-5000 EXCIMER LASER SYSTEM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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