PMA P840008
- Device
- DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S069
- Product code
- LNS
- Decision date
- 1999-09-02
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode.
Current openFDA PMA Record#
- Device
- DORNIER COMPACT DELTA LITHOTRIPTER-STATIONARY, MOBILE AND TRANSPORTABLE/FS2000 X-RAY MODULE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S069
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1999-09-02
- Decision code
- APRL
- Date received
- 1999-08-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change that would allow the option of a rotating x-ray anode in addition to the currently available stationary anode.