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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceND:YAG POSTERIOR CAPSULOTOMY MODEL 100
Generic NameLaser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
ApplicantNidek, Inc.
47651 Westinghouse Dr.
Fremont, CA 94539
PMA NumberP830062
Supplement NumberS011
Date Received03/23/1987
Decision Date06/11/1987
Withdrawal Date11/27/2013
Product Code LOI 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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