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 | TRANSPORTABLE MODEL STS-T LITHOTRIPTER |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 ALISO VIEJO, CA 92656-4114 |
PMA Number | P870015 |
Supplement Number | S034 |
Date Received | 11/16/1999 |
Decision Date | 11/19/1999 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for minor changes to the hardware (i.e., modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positionere, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i.e., upgrade to version 1999.3), as well as minor changes tot he device's labeling. |
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