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 | ECONOLITH(TM) LITHOTRIPTER |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | MEDISPEC, LTD. 19110 MONTGOMERY VILLAGE AVE. SUITE 100 MONTGOMERY VILLAGE, MD 20886 |
PMA Number | P950043 |
Supplement Number | S001 |
Date Received | 06/25/1997 |
Decision Date | 06/30/1997 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A TRANSPORTABLE VERSION OF THE ECONOLITH(TM) LITHOTRIPTER. |
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