LITHOSTAR MULTILINE
FDA premarket approval P870018/S017 · decided 1998-08-26
Approval details
- PMA number
- P870018
- Supplement
- S017
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LITHOSTAR MULTILINE
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1997-06-17
- Decision date
- 1998-08-26
- Days to decision
- 435 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- 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.
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