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 | TECHNOMED INTERNATIONAL SONOLITH 3000 |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | EDAP INTERNATIONAL CORP. TWO BURLINGTON WOODS BURLINGTON, MA 01803 |
PMA Number | P880011 |
Supplement Number | S008 |
Date Received | 03/08/1994 |
Decision Date | 04/18/1994 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
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