Note: 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. |
|
Device | MEDSTONE STS LITHOTRIPTER |
Generic Name | Lithotripter, shockwave (for treating gallbladder stones) |
Applicant | MEDSTONE INTL., INC. 100 COLUMBIA, SUITE 100 ALISO VIEJO, CA 92656-4114 |
PMA Number | P970042 |
Supplement Number | S002 |
Date Received | 02/21/2002 |
Decision Date | 08/20/2002 |
Withdrawal Date
|
02/10/2004 |
Product Code |
NCV |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR 1) THE USE OF TWO GENERIC URSODIOLS, ONE MANUFACTURED BY AMIDE PHARMACEUTICAL AND ONE BY TEVA PHARMACEUTICAL, IN ADDITION TO ACTIGALL; 2) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR TO JOAN L. DRUCKER M.D., R.S.I.; AND 3) SEVERAL MINOR CLARIFICATIONS, CORRECTIONS AND EDITORIAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, MEDSTONE STS LITHOTRIPTER, AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES (BETWEEN 4 AND 20 MM IN MAXIMUM DIAMETER) IN ADULTS 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. |
|
|