PMA P920034S003

Device: TRIPTER-X1
Applicant: Medirex, Inc.
PMA number: P920034
Supplement: S003
Product code: LNS
Decision date: 1998-12-14
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Approval order statement: 1)Contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the Tripter-X1's labeling to reflect the results of this final report.

Current openFDA PMA Record

Device: TRIPTER-X1
Applicant: Medirex, Inc.
PMA number: P920034
Supplement: S003
Product code: LNS
Generic name: Lithotriptor, extracorporeal shock-wave, urological
Decision date: 1998-12-14
Decision code: APRL
Date received: 1998-11-12
Supplement type: Normal 180 Day Track
Supplement reason: Postapproval Study Protocol
Approval order statement: 1)Contained the final report of postapproval study regarding the possible relationship between extracorporeal shock wave lithotripsy and the onset of hypertension, and 2) requested approval for modifications to the Tripter-X1's labeling to reflect the results of this final report.