PMA P840008S062
- Device
- DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S062
- Product code
- LNS
- Decision date
- 1998-05-14
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for hardware and software modifications to the Dornier Lithotripter and Dornier Compact S Lithotripter, including modifications to the shock wave therapy source of each system.
Current openFDA PMA Record#
- Device
- DORNIER LITHOTRIPTER AND DORNIER COMPACT S LITHOTRIPTER
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S062
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1998-05-14
- Decision code
- APRL
- Date received
- 1998-02-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for hardware and software modifications to the Dornier Lithotripter and Dornier Compact S Lithotripter, including modifications to the shock wave therapy source of each system.