MEDSTONE STS-TC/U LITHOTRIPTER
FDA premarket approval P970042/S003 · decided 2003-02-14
Approval details
- PMA number
- P970042
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTONE STS-TC/U LITHOTRIPTER
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Applicant
- Medstone Intl., Inc.
- Date received
- 2002-07-03
- Decision date
- 2003-02-14
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- NCV
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- 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
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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 |