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 | S035 |
Date Received | 02/15/2000 |
Decision Date | 02/25/2000 |
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 (1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and (2) the additon of protective covers for the U-arm's electrical connections. |
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