- Device
- STORZ MODULITH LITHOTRIPTER, MODEL SLX
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- PMA number
- P920051
- Supplement
- S003
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1996-06-21
- Decision code
- APRL
- Date received
- 1996-04-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW MODEL LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH LITHOTRIPTER, MODEL SLX