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. |
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Device | STORZ MODULITH (TM) LITHOTRIPTER |
Generic Name | Lithotriptor, extracorporeal shock-wave, urological |
Regulation Number | 876.5990 |
Applicant | KARL STORZ ENDOSCOPY-AMERICA, INC. 1201 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P920051 |
Date Received | 11/24/1992 |
Decision Date | 02/17/1995 |
Reclassified Date
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09/08/2000 |
Product Code |
LNS |
Docket Number | 95m-0396 |
Notice Date | 12/15/1995 |
Advisory Committee |
Gastroenterology/Urology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement STORZ MODULITH LITHOTRIPTER, MODEL SL20 - THE DEVICE IS AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 |
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