STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)
FDA premarket approval P920051/S004 · decided 1997-01-10
Approval details
- PMA number
- P920051
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 1996-08-30
- Decision date
- 1997-01-10
- Days to decision
- 133 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL OF A MOBILE VERSION OF THE MODULITH(R) SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH(R) SLX MOBILE LITHOTRIPTER, AND IS INDICATED FOR USE IN THE NONINVASIVE GRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.
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