Lithotripter, Shockwave (For Treating Gallbladder Stones)
Basic Information
- Device Name
- Lithotripter, Shockwave (For Treating Gallbladder Stones)
- Trade Name
- MEDSTONE STS LITHOTRIPTER
- PMA Number
- P970042
- Device Class
- FDA Class 3
- Product Code
- NCV
- Generic Name
- Lithotripter, shockwave (for treating gallbladder stones)
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- September 5, 2000
- Date Received
- September 4, 1997
- Expedited Review
- N
- Docket Number
- 00M-1515
Advisory Committee Statement
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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NCV | Lithotripter, Shockwave (For Treating Gallbladder Stones) | FDA class 3 | Unknown |