- Device
- LITHOSTAR LITHOTRIPTER SHOCK WAVE SYSTEM C
- Applicant
- Siemens Corp.
- PMA number
- P870018
- Supplement
- S014
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-06-06
- Decision code
- APRL
- Date received
- 1996-03-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1)MODIFICATIONS TO A PROGRAMMABLE READ ONLY MEMORY INTEGRATED CIRCUIT; AND 2)MINOR LABELING CHANGES. THE DEVICE AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAME LITHOSTAR SHOCK WAVE SYSTEM C