PMA P870015S034
- Device
- TRANSPORTABLE MODEL STS-T LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S034
- Product code
- LNS
- Decision date
- 1999-11-19
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for minor changes to the hardware (i.e., modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positionere, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i.e., upgrade to version 1999.3), as well as minor changes tot he device's labeling.
Current openFDA PMA Record#
- Device
- TRANSPORTABLE MODEL STS-T LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S034
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1999-11-19
- Decision code
- APRL
- Date received
- 1999-11-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor changes to the hardware (i.e., modification to the remote control, addition of a foot switch, increase in the travel distance of the shockwave positionere, and modification to the printed circuit board that interfaces the computer with the axis controllers) and software (i.e., upgrade to version 1999.3), as well as minor changes tot he device's labeling.