PMA P870015S033
- Device
- MEDSTONE STS-T LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S033
- Product code
- LNS
- Decision date
- 1999-06-21
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for use of an alternate ECG monitor, minor software upgrades to version 1999.2, and associated changes to the device labeling.
Current openFDA PMA Record#
- Device
- MEDSTONE STS-T LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S033
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1999-06-21
- Decision code
- APRL
- Date received
- 1999-06-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of an alternate ECG monitor, minor software upgrades to version 1999.2, and associated changes to the device labeling.