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 | ND:YAG POSTERIOR CAPSULOTOMY MODEL 100 |
Generic Name | Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary |
Applicant | NIDEK, INC. 47651 WESTINGHOUSE DR. FREMONT, CA 94539 |
PMA Number | P830062 |
Supplement Number | S012 |
Date Received | 03/15/1988 |
Decision Date | 07/28/1988 |
Withdrawal Date
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11/27/2013 |
Product Code |
LOI |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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