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 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.
 
DeviceMEDSTONE STS LITHOTRIPTER
Generic NameLithotripter, shockwave (for treating gallbladder stones)
ApplicantMEDSTONE INTL., INC.
100 COLUMBIA, SUITE 100
ALISO VIEJO, CA 92656-4114
PMA NumberP970042
Supplement NumberS001
Date Received12/18/2000
Decision Date02/05/2001
Withdrawal Date 02/10/2004
Product Code NCV 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR SEVERAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. SPECIFICALLY, THESE CHANGES ARE 1) CHANGES TO INCLUSION CRITERIA 3 AND 5 2) CHANGES TO EXCLUSION CRITERIA 7, 8, 9, 10, 11, 13, 15, AND 16 3) ELIMINATION OF THE ULTRASOUND EVALUATION IMMEDIATELY POST-LITHOTRIPSY, 4) ELIMINATION OF THE ORAL CHOLECYSTOGRAM AT THE SIX-MONTH VISIT, AND 5) ADDITION OF STATEMENTS TO CLARIFY GUIDELINES FOR SCHEDULING FOLLOW-UP VISITS AND TO LIST PROTOCOL REQUIREMENTS BY STUDY VISIT.
-
-