PMA P920051S004

Device: STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S004
Product code: LNS
Decision date: 1997-01-10
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: APPROVAL OF A MOBILE VERSION OF THE MODULITH(R) SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH(R) SLX MOBILE LITHOTRIPTER, AND IS INDICATED FOR USE IN THE NONINVASIVE GRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.

Current openFDA PMA Record#

Device: STORZ MODULITH LITHOTRIPTER, MODEL SLX FOR FRAGMENTATION OF URINARY AND UPPER URETERAL CALCULI (MOBILE VERSION)
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S004
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1997-01-10
Decision code: APRL
Date received: 1996-08-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL OF A MOBILE VERSION OF THE MODULITH(R) SLX LITHOTRIPTER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE STORZ MODULITH(R) SLX MOBILE LITHOTRIPTER, AND IS INDICATED FOR USE IN THE NONINVASIVE GRAGMENTATION OF URINARY CALCULI IN THE KIDNEY AND UPPER URETER.