MEDSTONE STS LITHOTRIPTER
FDA premarket approval P970042/S001 · decided 2001-02-05
Approval details
- PMA number
- P970042
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MEDSTONE STS LITHOTRIPTER
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Applicant
- Medstone Intl., Inc.
- Date received
- 2000-12-18
- Decision date
- 2001-02-05
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NCV
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- APPROVAL FOR SEVERAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. SPECIFICALLY, THESE CHANGES ARE 1) CHANGES TO INCLUSION CRITERIA 3 AND 5 2) CHANGES TO EXCLUSION CRITERIA 7, 8, 9, 10, 11, 13, 15, AND 16 3) ELIMINATION OF THE ULTRASOUND EVALUATION IMMEDIATELY POST-LITHOTRIPSY, 4) ELIMINATION OF THE ORAL CHOLECYSTOGRAM AT THE SIX-MONTH VISIT, AND 5) ADDITION OF STATEMENTS TO CLARIFY GUIDELINES FOR SCHEDULING FOLLOW-UP VISITS AND TO LIST PROTOCOL REQUIREMENTS BY STUDY VISIT.
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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 |