PMA P970019

Device: LITHOTRON ULS
Applicant: Healthtronics Surgical Services, Inc.
PMA number: P970019
Supplement: S006
Product code: LNS
Decision date: 1999-12-17
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for addition of an ultrasonic stone location accessory. The device is indicated for preliminary localization of a target stone prior to extracorporeal shock wave lithotripsy with the Lithotron(TM) Lithotripsy System. The indications for use have not changed.

Current openFDA PMA Record#

Device: LITHOTRON ULS
Applicant: Healthtronics Surgical Services, Inc.
PMA number: P970019
Supplement: S006
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1999-12-17
Decision code: APRL
Date received: 1999-07-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for addition of an ultrasonic stone location accessory. The device is indicated for preliminary localization of a target stone prior to extracorporeal shock wave lithotripsy with the Lithotron(TM) Lithotripsy System. The indications for use have not changed.