Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceHEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
Generic NameLithotriptor, extracorporeal shock-wave, urological
Regulation Number876.5990
ApplicantHEALTH TRONICS SURGICAL SERVICES, INC.
425 FRANKLIN RD., SUITE 545
MARIETTA, GA 30067
PMA NumberP970019
Date Received05/16/1997
Decision Date07/21/1997
Reclassified Date 09/08/2000
Product Code LNS 
Docket Number 97M-0453
Notice Date 11/14/1997
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
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 
-
-