PMA P840008S057
- Device
- MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S057
- Product code
- LNS
- Decision date
- 1997-04-29
- Classification
- Lithotriptor, Extracorporeal Shock-wave, Urological
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Approval order statement
- ApproVAL FOR NON-ECG SHOCK WAVE TRIGGER MODES FOR THE ABOVE DEVICES
Current openFDA PMA Record#
- Device
- MFL5000 & DORNIER LITHOTRIPTERS (STATIOINARY & TRANSPORTABLE)
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P840008
- Supplement
- S057
- Product code
- LNS
- Generic name
- Lithotriptor, extracorporeal shock-wave, urological
- Decision date
- 1997-04-29
- Decision code
- APRL
- Date received
- 1996-11-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- ApproVAL FOR NON-ECG SHOCK WAVE TRIGGER MODES FOR THE ABOVE DEVICES