This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the sts-tc/u lithotripter (transportable version of the sts lithotripter with ultrasound). The device, as modified, will be marketed under the trade name medstone sts-tc/u lithotripter and is indicated for 1) the fragmentation of symptomatic upper urinary tract stones, i. E. , renal calyceal stones, renal pelvic stones, and upper ureteral stones, and 2) when used in conjunction with certain ursodiols, 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 novartis pharmaceutical actigall. , or amide pharmaceutical ursodiol, or teva pharmaceutical ursodiol (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 ursodiol until a stone-free state is achieved.
| Device | MEDSTONE STS-TC/U LITHOTRIPTER |
| Generic Name | Lithotripter, Shockwave (for Treating Gallbladder Stones) |
| Applicant | MEDSTONE INTL., INC. |
| Date Received | 2002-07-03 |
| Decision Date | 2003-02-14 |
| PMA | P970042 |
| Supplement | S003 |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | MEDSTONE INTL., INC. 100 Columbia, Suite 100 aliso Viejo, CA 92656-4114 |
| 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 |