MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
FDA premarket approval P970042/S004 · decided 2003-01-28
Approval details
- PMA number
- P970042
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Applicant
- Medstone Intl., Inc.
- Date received
- 2002-08-02
- Decision date
- 2003-01-28
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NCV
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- APPROVAL FOR 1) A CHANGE IN THE INCLUSION AGE LIMIT FOR THE POST-APPROVAL STUDY FROM 18-70 TO 18 AND OVER; 2) A CHANGE IN THE POST APPROVAL STUDY'S MONITORING FROM RSI TO MEDSTONE; AND 3) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR FROM RSI TO MICHAEL ALBERT, M.D.
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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 |