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
|
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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