FDA.reportPublic FDA data

PMA P970042

Device
MEDSTONE STS-TC/U LITHOTRIPTER
Applicant
Medstone Intl., Inc.
PMA number
P970042
Supplement
S003
Product code
NCV
Decision date
2003-02-14
Generic name
Lithotripter, shockwave (for treating gallbladder stones)
Approval order statement
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.

Current openFDA PMA Record#

Device
MEDSTONE STS-TC/U LITHOTRIPTER
Applicant
Medstone Intl., Inc.
PMA number
P970042
Supplement
S003
Product code
NCV
Generic name
Lithotripter, shockwave (for treating gallbladder stones)
Decision date
2003-02-14
Decision code
APPR
Date received
2002-07-03
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
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.