STORZ MODULITH LITHOTRIPTER, MODEL SLX
FDA premarket approval P920051/S005 · decided 1996-12-27
Approval details
- PMA number
- P920051
- Supplement
- S005
- 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
- 1996-10-08
- Decision date
- 1996-12-27
- Days to decision
- 80 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR CHANGES TO THE X-RAY IMAGING SYSTEM OF THE STORZ MODULITH(R) LITHOTRIPTER, MODEL SLX.
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