PMA P970019S003

Device: HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
Applicant: Healthtronics Surgical Services, Inc.
PMA number: P970019
Supplement: S003
Product code: LNS
Decision date: 1998-11-18
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: Approval for modifications to the LithoTron(TM) Lithotripsy System's labeling to reflect the results of this final report. Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that this postapproval requirement is now considered complete.

Current openFDA PMA Record#

Device: HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM
Applicant: Healthtronics Surgical Services, Inc.
PMA number: P970019
Supplement: S003
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1998-11-18
Decision code: APRL
Date received: 1998-07-23
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for modifications to the LithoTron(TM) Lithotripsy System's labeling to reflect the results of this final report. Based upon the information submitted, FDA believes that the postapproval report demonstrates that hypertension is not a long-term risk of extracorporeal shock wave lithotripsy, and that this postapproval requirement is now considered complete.