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.
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.
| Device | MEDSTONE STS LITHOTRIPTER |
| Classification Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Generic Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Applicant | MEDSTONE INTL., INC. |
| Date Received | 1997-09-04 |
| Decision Date | 2000-09-05 |
| Notice Date | 2000-09-15 |
| PMA | P970042 |
| Supplement | S |
| Product Code | NCV |
| Docket Number | 00M-1515 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDSTONE INTL., INC. 100 Columbia, Suite 100 aliso Viejo, CA 92656-4114 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970042 | Original Filing | |
| S004 | 2002-08-02 | Normal 180 Day Track |
| S003 | 2002-07-03 | Normal 180 Day Track |
| S002 | 2002-02-21 | Normal 180 Day Track |
| S001 | 2000-12-18 | Normal 180 Day Track |