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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceMEDSTONE STS LITHOTRIPTER
Classification Namelithotripter, shockwave (for treating gallbladder stones)
Generic Namelithotripter, shockwave (for treating gallbladder stones)
Applicant
MEDSTONE INTL., INC.
100 columbia, suite 100
aliso viejo, CA 92656-4114
PMA NumberP970042
Supplement NumberS001
Date Received12/18/2000
Decision Date02/05/2001
Product Code
NCV
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product Yes
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.
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