STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
FDA premarket approval P920051/S006 · decided 1997-03-27
Approval details
- PMA number
- P920051
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Date received
- 1997-03-26
- Decision date
- 1997-03-27
- Days to decision
- 1 days
- Decision code
- APRL
- Product code
- LNS
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR THE OEC SERIES 9600 MOBILE IMAGING UNIT AND A PORTABLE COLLISION PROTECTOR TO BE USED WITH A TRANSPORTABLE VERSION OF YOUR SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TRANSPORTABLE MODULITH(R) SLX LITHOTRIPTER AND IS INDICATED FOR USE IN THE NONINVASIVE FRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.