LITHOSTAR
FDA premarket approval P870018/S010 · decided 1995-07-13
Approval details
- PMA number
- P870018
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LITHOSTAR
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1995-05-08
- Decision date
- 1995-07-13
- Days to decision
- 66 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- Statement
- APPROVAL FOR A MODIFIED IMAGE INTENSIFIER TO BE USED WITH THE LITHOSTAR SYSTEM
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