| 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 | MEDSTONE STS LITHOTRIPTER |
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| Generic Name | Lithotripter, shockwave (for treating gallbladder stones) |
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| Applicant | MEDSTONE INTL., INC.
100 COLUMBIA, SUITE 100
ALISO VIEJO, CA 92656-4114 |
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| PMA Number | P970042 |
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| Date Received | 09/04/1997 |
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| Decision Date | 09/05/2000 |
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Withdrawal Date
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02/10/2004 |
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| Product Code |
NCV |
| Docket Number | 00M-1515 |
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| Notice Date | 09/15/2000 |
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| Advisory Committee |
Gastroenterology/Urology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE MEDSTONE STS(TM) LITHOTRIPTER IN CONJUNCTION WITH ACTGALL(R). WHEN USED WITH THE DRUG, THIS DEVICE IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULT PATIENTS FOR WHOM SURGICAL REMOVAL OF THE GALLBLADDER IS MEDICALLY CONTRAINDICATED AND IN SYMPTOMATIC HIGH-RISK PATIENTS WHO HAVE ACTIVELY REFUSED SURGERY. COMBINATION THERAPY CONSISTS OF 1) ADMINISTRATION OF ACTIGALL(R) (8-10 MG/KG/DAY) FOR AT LEAST TWO WEEKS PRE-LITHOTRIPSY, 2) LITHOTRIPSY TREATMENTS OF UP TO 2000 24 KV SHOCKS, AND 3) CONTINUED ADMINISTRATION OF ACTIGALL(R) UNTIL A STONE-FREE STATE IS ACHIEVED. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S003 S004 |
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