PMA P950043S006
- Device
- ECONOLITH LITHOTRIPTER
- Applicant
- Medispec, Ltd.
- PMA number
- P950043
- Supplement
- S006
- Product code
- LNS
- Decision date
- 1999-08-27
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for the final report of the postapproval study regarding the possible relationship between extracorporeal shcok wave lithotripsy and the onset of hypertension, and 2) modifications tothe Econolith(TM) Lithotripter's labeling to reflect the results of the 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 the postapproval requirement is now complete.
Current openFDA PMA Record#
- Device
- ECONOLITH LITHOTRIPTER
- Applicant
- Medispec, Ltd.
- PMA number
- P950043
- Supplement
- S006
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1999-08-27
- Decision code
- APRL
- Date received
- 1999-05-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the final report of the postapproval study regarding the possible relationship between extracorporeal shcok wave lithotripsy and the onset of hypertension, and 2) modifications tothe Econolith(TM) Lithotripter's labeling to reflect the results of the 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 the postapproval requirement is now complete.