MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
FDA premarket approval P870015/S021 · decided 1995-09-15
Approval details
- PMA number
- P870015
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDSTONE STS(TM) EXTRACORPOREAL SHOCK WAVE LITHOTR
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Medstone Intl., Inc.
- Date received
- 1995-07-13
- Decision date
- 1995-09-15
- Days to decision
- 64 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Aliso Viejo, CA
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS:USE OF ALTERNATE ULTRASOUND IMAGING UNIT; USE OF ALTERNATE DIGITIZER PAD; MODIFICATION OF SYSTEM SOFTWARE TO VERSION 7.10; AND REVISIONS TO SYSTEMS USER'S MANUAL
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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 |