MEDSTONE STS LITHOTRIPTER
FDA premarket approval P970042/S002 · decided 2002-08-20
Approval details
- PMA number
- P970042
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDSTONE STS LITHOTRIPTER
- Generic name
- Lithotripter, shockwave (for treating gallbladder stones)
- Applicant
- Medstone Intl., Inc.
- Date received
- 2002-02-21
- Decision date
- 2002-08-20
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- NCV
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- APPROVAL FOR 1) THE USE OF TWO GENERIC URSODIOLS, ONE MANUFACTURED BY AMIDE PHARMACEUTICAL AND ONE BY TEVA PHARMACEUTICAL, IN ADDITION TO ACTIGALL; 2) A CHANGE IN THE POST-APPROVAL STUDY'S MEDICAL MONITOR TO JOAN L. DRUCKER M.D., R.S.I.; AND 3) SEVERAL MINOR CLARIFICATIONS, CORRECTIONS AND EDITORIAL CHANGES TO THE POST-APPROVAL STUDY PROTOCOL. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME, MEDSTONE STS LITHOTRIPTER, AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC, SOLITAR
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |