STORZ MODULITH (TM) LITHOTRIPTER
FDA premarket approval P920051 · decided 1995-02-17
Approval details
- PMA number
- P920051
- Trade name
- STORZ MODULITH (TM) LITHOTRIPTER
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 1992-11-24
- Decision date
- 1995-02-17
- Days to decision
- 815 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- STORZ MODULITH LITHOTRIPTER, MODEL SL20 - THE DEVICE IS AN EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
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