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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
Classification Namelithotriptor, extracorporeal shock-wave,urological
Regulation Number876.5990
ApplicantMEDSTONE INTL., INC.
PMA NumberP970042
Supplement NumberS004
Date Received08/02/2002
Decision Date01/28/2003
Product Code
LNS[ Registered Establishments with LNS ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 1) a change in the inclusion age limit for the post-approval study from 18-70 to 18 and over; 2) a change in the post approval study's monitoring from rsi to medstone; and 3) a change in the post-approval study's medical monitor from rsi to michael albert, m. D.
-
-