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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.
Classification Namelithotripter, shockwave (for treating gallbladder stones)
Generic Namelithotripter, shockwave (for treating gallbladder stones)
100 columbia, suite 100
aliso viejo, CA 92656-4114
PMA NumberP970042
Supplement NumberS001
Date Received12/18/2000
Decision Date02/05/2001
Product Code
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.