PMA P840008S058
- Device
- DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S058
- Product code
- LNS
- Decision date
- 1997-05-05
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- APPROVAL FOR A NON-ECG SHOCK WAVE TRIGGER MODE FOR THE DORNIER COMPACT S AND THE MOVE AND SHOOT FEATURE FOR THE DORNIER LITHOTRIPTER (STATIONARY AND TRANSPORTABLE).
Current openFDA PMA Record#
- Device
- DORNIER COMPACT S) AND DORNIER LITHOTRIPTER (STATIONARY & TRANSPORTABLE
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S058
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1997-05-05
- Decision code
- APRL
- Date received
- 1996-12-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NON-ECG SHOCK WAVE TRIGGER MODE FOR THE DORNIER COMPACT S AND THE MOVE AND SHOOT FEATURE FOR THE DORNIER LITHOTRIPTER (STATIONARY AND TRANSPORTABLE).