PMA P870015S035
- Device
- TRANSPORTABLE MODEL STS-T LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S035
- Product code
- LNS
- Decision date
- 2000-02-25
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for (1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and (2) the additon of protective covers for the U-arm's electrical connections.
Current openFDA PMA Record#
- Device
- TRANSPORTABLE MODEL STS-T LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S035
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 2000-02-25
- Decision code
- APRL
- Date received
- 2000-02-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for (1) minor changes to the labeling to minimize the risk of electrical shock from the U-arm, and (2) the additon of protective covers for the U-arm's electrical connections.