MEDSTONE STS LITHOTRIPTER
FDA premarket approval P970042 · decided 2000-09-05
Approval details
- PMA number
- P970042
- Trade name
- MEDSTONE STS LITHOTRIPTER
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Applicant
- Medstone Intl., Inc.
- Date received
- 1997-09-04
- Decision date
- 2000-09-05
- Days to decision
- 1097 days
- Decision code
- APWD
- Product code
- NCV
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- 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)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION (K013620) | Medstone Intl., Inc. | 2002-01-22 |
| STS-T LITHOTRIPTER, MODEL STS-T (K010900) | Medstone Intl., Inc. | 2001-04-05 |
| STS(TM) FLUOROSCOPIC IMAGING MODULE (K905278) | Medstone Intl., Inc. | 1991-02-04 |