Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | HEALTH TRONICS SURGICAL SERVICES, INC. 425 FRANKLIN RD., SUITE 545 MARIETTA, GA 30067 |
PMA Number | P970019 |
Date Received | 05/16/1997 |
Decision Date | 07/21/1997 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Docket Number | 97M-0453 |
Notice Date | 11/14/1997 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LITHOTRON(TM) LITHOTRIPSY SYSTEM. THIS DEVICE IS INDICATED FOR USE IN PATIENTS WITH RENAL AND UPPER URETERAL CALCULI BETWEEN 4 AND 20 MM IN SIZE. |
Supplements: |
S001 S002 S003 S004 S005 S006 |
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