LITHOSTAR SHOCK WAVE SYSTEM C
FDA premarket approval P870018/S011 · decided 1996-03-01
Approval details
- PMA number
- P870018
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LITHOSTAR SHOCK WAVE SYSTEM C
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1995-09-05
- Decision date
- 1996-03-01
- Days to decision
- 178 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- 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
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