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 | LITHOSTAR SHOCK WAVE SYSTEM C |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | SIEMENS CORP. 186 WOOD AVE., SOUTH ISELIN, NJ 08830 |
PMA Number | P870018 |
Supplement Number | S011 |
Date Received | 09/05/1995 |
Decision Date | 03/01/1996 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS MADE TO THE SHOCK TUBE, WATER CONDITIONING SYSTEM, SHOCK WAVE GENERATOR, SHOCK WAVE ENERGY SETTING, AND LABELING. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C |
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