PMA P970042S002
- Device
- MEDSTONE STS LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P970042
- Supplement
- S002
- Product code
- NCV
- Decision date
- 2002-08-20
- Classification
- Lithotripter, Shockwave (for Treating Gallbladder Stones)
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- 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.
Current openFDA PMA Record#
- Device
- MEDSTONE STS LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P970042
- Supplement
- S002
- Product code
- NCV
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Decision date
- 2002-08-20
- Decision code
- APPR
- Date received
- 2002-02-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.