- Device
- LITHOSTAR SHOCK WAVE SYSTEM C
- Applicant
- Siemens Corp.
- PMA number
- P870018
- Supplement
- S011
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-03-01
- Decision code
- APRL
- Date received
- 1995-09-05
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS MADE TO THE SHOCK TUBE, WATER CONDITIONING SYSTEM, SHOCK WAVE GENERATOR, SHOCK WAVE ENERGY SETTING, AND LABELING. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C