MODULARIS LITHO
FDA premarket approval P870018/S021 · decided 1998-09-21
Approval details
- PMA number
- P870018
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODULARIS LITHO
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1998-05-01
- Decision date
- 1998-09-21
- Days to decision
- 143 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- Statement
- Approval for a compact transportable (within the hospital only) configuration of the Lithostar(R) Shock Wave System C. The device, as modified, will be marketed under the trade name Lithostar(R) Modularis and is indicated for use in the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.
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