PMA P870015S029
- Device
- MEDSTONE STS(TM) LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S029
- Product code
- LNS
- Decision date
- 1998-03-27
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for modification of the Medstone STS(TM) Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-30-ESU).
Current openFDA PMA Record#
- Device
- MEDSTONE STS(TM) LITHOTRIPTER
- Applicant
- Medstone Intl., Inc.
- PMA number
- P870015
- Supplement
- S029
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-03-27
- Decision code
- APRL
- Date received
- 1998-03-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modification of the Medstone STS(TM) Lithotripter to include an alternate model x-ray generator (i.e., the Creos XHF-30-ESU).