- Device
- LITHOSTAR MULTILINE
- Applicant
- Siemens Corp.
- PMA number
- P870018
- Supplement
- S017
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-08-26
- Decision code
- APRL
- Date received
- 1997-06-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new configuration of the Lithostar(R). The device, as modified, will be marketed under the trade name Lithostar(R) Multiline and is indicated for use in patients with renal and upper ureteral caculi between 5mm and 15mm.