STORZ MODULITH LITHOTRIPTER, MODEL SLX
FDA premarket approval P920051/S003 · decided 1996-06-21
Approval details
- PMA number
- P920051
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STORZ MODULITH LITHOTRIPTER, MODEL SLX
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 1996-04-17
- Decision date
- 1996-06-21
- Days to decision
- 65 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR A NEW MODEL LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH LITHOTRIPTER, MODEL SLX
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