TRANSMOBILE LITHOSTAR MODULARIS
FDA premarket approval P870018/S022 · decided 1999-01-21
Approval details
- PMA number
- P870018
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TRANSMOBILE LITHOSTAR MODULARIS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- Siemens Corp.
- Date received
- 1999-01-12
- Decision date
- 1999-01-21
- Days to decision
- 9 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Iselin, NJ
- Statement
- Approval for a transportable (between hospitals) Lithostar Modularis.
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|---|---|---|
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| AX WORKSTATION DR-VIEWER SOFTWARE OPTION (K992925) | Siemens Corp. | 1999-11-23 |
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| SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION (K991600) | Siemens Corp. | 1999-06-09 |
| FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR (K984221) | Siemens Corp. | 1999-02-12 |
| PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS (K984224) | Siemens Corp. | 1999-02-02 |
| PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE (K982536) | Siemens Corp. | 1998-11-24 |