PMA P920051S006

Device: STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S006
Product code: LNS
Decision date: 1997-03-27
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order 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.

Current openFDA PMA Record#

Device: STORZ TRANSPORTABLE MODULITH SLX LITHOTRIPTER VERSION) ANSPORTABLE VERSION)
Applicant: KARL STORZ Endoscopy-America, Inc.
PMA number: P920051
Supplement: S006
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1997-03-27
Decision code: APRL
Date received: 1997-03-26
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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.